Ovarian CancerPhase 1NCT00652119
Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin
A Phase 1 study testing Paclitaxel, Carboplatin and Avastin in people with Ovarian Cancer and Peritoneal Cancer, run by Massachusetts General Hospital at 5 sites in United States.
Trial summary
The goal of this clinical research study is to learn about the safety and tolerability of paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian, primary peritoneal, or fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Paclitaxel, Carboplatin and Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2008to Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.
- Stage III or IV disease. Stage IV disease by virtue of pleural effusions is allowed but stage IV disease with visceral metastases e.g. lung, liver or abdominal wall is NOT ELIGIBLE. Please discuss any eligibility concerns directly with the P.I., Dr. Richard Penson.
- Patient must have undergone surgical staging and debulking with optimal (less than 1cm) cytoreduction.
- No significant intra-abdominal adhesions or other contraindication to IP port placement.
- Patients must give written informed consent.
- Patient must be age 18 years or older.
Show all 9Show fewer
- Adequate bone marrow function with an ANC greater that 2,500 and Platelets greater than 100,000 cubic millimeters.
- No proteinuria or less than +1; if greater, 24-hour urine collection must be performed to document less than or equal to 1gm/24 hours of protein.
- ECOG performance status less than or equal to 1.
Who cannot join
- Visible disease on post-operative imaging (recognizing the limitations of postoperative CT scans due to postoperative changes there should be unequivocal CT evidence of residual disease greater than 1cm)
- ECOG performance status greater than or equal to 2
- Previous chemotherapy for the disease under study
- Suboptimal (greater than 1 cm residual disease) cytoreduction
- Creatinine greater than 1.5 mg/dL
- SGOT greater than 2 x ULN, bilirubin greater than 1.5 x ULN
Show all 25Show fewer
- Colostomy or ileostomy
- Concurrent invasive malignancy. (Patients with concurrent superficial endometrial carcinoma are eligible if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium.)
- Known hypersensitivity to E.coli derived products or to any component of Avastin
- Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely
- History of myocardial infarction within 6 months
- History of stroke or transient ischemia attack within 6 months
- Inadequately controlled hypertension greater than 140/90 mm Hg on antihypertensive medication(s)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Clinically significant peripheral vascular disease
- Significant vascular disease (e.g. aortic aneurysm, aortic dissection)
- Unstable angina
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Evidence of coagulopathy or bleeding diathesis
- Known central nervous system disease or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 28 (first dose of Avastin), anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures such as fine needle aspirations or core biopsies or laparoscopy for IP catheter placement within 7 days prior to cycle 2 day 8
- Open wound, ulcer, or bone fracture
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; current signs and symptoms of bowel obstruction; current dependency on IV hydration or TPN
- Pregnant (positive pregnancy test) or lactating
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Pilot Trial of Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin
The goal of this clinical research study is to learn about the safety and tolerability of paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian, primary peritoneal, or fallopian tube cancer.
Objectives:
Read more
Primary study goals:
To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in combination with IV Avastin To determine if Avastin influences the pharmacokinetics of IP administered chemotherapeutic agents
Secondary study goals:
To determine the systemic exposure to paclitaxel and carboplatin during initial and late cycles of IP dosing.
To collect overall survival (OS) and progression-free survival (PFS) To determine changes in IP VEGF levels To determine site of first recurrence Information on CA-125 response and clinical response will be descriptive as secondary goals of this study
Exploratory goal:
To estimate proportion of patients completing entire course of treatment
Read the detailed description
The Study Drugs:
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may cause them to die.
Avastin is designed to prevent or slow down the growth of cancer cells by blocking the effects of VEGF, a blood-vessel stimulating agent that plays an important role in the growth of both normal and abnormal blood vessels.
Intraperitoneal Port (IP) Placement:
If you are found eligible to take part in this study, you will need to have an IP port, called an intraperitoneal catheter tube, placed into the abdomen. The catheter will be used to give the paclitaxel and carboplatin directly into your abdomen. You may already have had this catheter placed at a previous surgery. If not, you will have a minor surgical procedure in the operating room to have it placed. You will be asked to sign a separate surgical consent form describing this procedure, the risks involved, and the steps for taking care of the catheter while it is in place.
Study Drug Administration:
You will receive up to 6 cycles of treatment with the study drugs. Each cycle is 21 days (3 weeks) long.
Cycle 1:
You will receive paclitaxel and carboplatin through a needle in your vein on Day 1. Paclitaxel is given first followed by carboplatin. Both drugs are given over 1 hour. On Days 8 and 15 you will only receive paclitaxel by vein. This infusion is also given over 1 hour.
Cycle 2:
On Day 1, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. This infusion takes 30-60 minutes. You will then receive paclitaxel through the IP port in your abdomen. When the paclitaxel infusion is complete, you will receive carboplatin through the IP port. Each infusion takes about 1 hour. After the chemotherapy infusions are complete, another 2-4 cups of normal saline will be infused through the port. This is done to help move the chemotherapy to all areas of your abdomen. You will be asked to change position frequently.
On Day 8, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. You will then receive paclitaxel through the IP port in your abdomen over 1 hour. While you are receiving paclitaxel through your IP port, you will also receive Avastin by vein. The first dose of Avastin will be given over 90 minutes. If you tolerate the first infusion well, the second infusion (given in Cycle 3) may be given over 60 minutes. If the 60-minute infusion is well-tolerated, all infusions after that may be given over 30 minutes. After the paclitaxel infusion is complete, you will receive another 2-4 cups of normal saline through the port. You will be asked to change position frequently.
On Day 15, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. You will then receive paclitaxel through the IP port in your abdomen. After the paclitaxel infusion is complete, you will receive another 2-4 cups of normal saline through the port. You will be asked to change position frequently.
Cycles 3-6:
On Day 1, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. You will receive paclitaxel through the IP catheter over 1 hour. After completing paclitaxel, you will receive carboplatin through the IP catheter over 1 hour. After these infusions are complete you will receive another 2-4 cups of normal saline through the port. You will be asked to change position frequently. While undergoing IP therapy with paclitaxel and carboplatin, you will also receive the second infusion of Avastin by vein. The length of this infusion will depend how well you tolerated the drug the first time it was given in Cycle 2.
On Days 8 and 15, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. You will then receive paclitaxel through the IP port in your abdomen over 1 hour. After the paclitaxel infusion is complete, you will receive another 2-4 cups of normal saline through the port. You will be asked to change position frequently.
Before you receive paclitaxel and carboplatin, you will receive the drug dexamethasone by vein to help decrease the risk of study drug side effects. You may also receive other drugs (such as cimetidine and diphenhydramine) by vein to help with side effects, such as nausea and allergic reaction. The choice of which drugs to use is up to your doctor.
Study Visits:
On Day 1 of each cycle, the following tests and procedures will be performed:
- Your medical history will be recorded, including a list of any drugs you are taking.
- You will be asked how well you are able to perform your normal daily activities (performance status evaluation).
- You will have physical exam, measurement of your vital signs, and a neurological exam.
- You will be asked about any side effects you are experiencing.
- Blood (about 3 teaspoons) will be drawn for routine tests (this will be repeated on Days 8 and 15 of each cycle as well).
Blood (about 1 teaspoon) will be drawn to check your CA125 level before treatment starts in Cycle 1 and on Day 1 of Cycles 2, 4, and 6.
Before treatment starts in Cycle 1 and on Day 8 of Cycle 2 and Day 1 of Cycles 3-6, urine will be collected for routine tests.
On Days 1, 8, and 15 of Cycles 1, 2, and 4, blood (1 teaspoon each time) will be drawn 12 different times each day for pharmacokinetic (PK) testing. PK testing measures the amount of study drugs in the body at different time points. Blood (1 teaspoon each time) will also be drawn 1 time on Days 2 and 3 of Cycles 1, 2, and 4.
On Day 8 of Cycle 2 and Day 1 of Cycles 3, 4, and 6 before paclitaxel starts, you will have the levels of vascular endothelial growth factor (VEGF) in your abdominal fluid measured. VEGF is a protein that causes fluid build-up (ascites) in the abdomen. About 2 cups of normal saline will be infused through the IP port. You will be asked to change positions for about 15 minutes. Then about 3-4 tablespoons of the fluid will be removed from the port with a syringe. This shows how Avastin is affecting your abdominal fluid. You will also have blood (about 1 teaspoon) drawn to check the levels of VEGF in your blood.
Length of Study:
You may remain on this study for up to 6 cycles. You will be taken off study early if the disease gets worse or intolerable side effects occur.
End-of-Study Visit:
Once you are off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam.
- You will have a computed tomography (CT) scan.
- Blood (about 1 teaspoon) will be drawn to check your CA125 level.
Long-Term Follow-Up:
After your last study visit, you will be contacted about every 3 months from then on to check on how you are doing. You will return to the clinic or researchers will call you on the phone to ask you questions about how you are doing. Your doctor will tell you if any standard tests and procedures need to be performed.
This is an investigational study. Avastin, carboplatin, and paclitaxel are FDA approved and commercially available for the treatment of many types of cancer. At this time, the addition of Avastin to paclitaxel and carboplatin is being used to treat ovarian cancer in research only.
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Being tested
- Paclitaxel, Carboplatin, Avastin
- Keywords
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Carcinoma of Mullerian Origin, Paclitaxel, Taxol, Carboplatin, Paraplatin®, Avastin, Bevacizumab, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
Cycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle.
CarboplatinDrug
Also called Paraplatin®
Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle.
AvastinDrug
Also called Bevacizumab, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Cycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel + Carboplatin + Avastin | Experimental | Paclitaxel Cycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle.
Carboplatin Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle.
Avastin Cycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle. Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Complete Entire Treatment Course
Rate of completers estimated along with a 95% confidence interval to evaluate the tolerability of this regimen.
Measured: Total treatment course = 6 cycles (1 cycle is 21 days)
Systemic Exposure to Paclitaxel and Carboplatin
Primary objective of pharmacokinetic studies is to determine whether rate and extent absorption of paclitaxel and carboplatin into systemic circulation when given by the intraperitoneal port (IP) route is influenced by concurrent administration of Avastin by vein. Sampling to define plasma concentration time courses of paclitaxel and carboplatin performed during second cycle without Avastin and fourth cycle of therapy with Avastin. Pharmacokinetic parameters and variables calculated according to standard equations. Concentration-time profiles of carboplatin and its metabolites analyzed by noncompartmental methods and/or nonlinear least squares regression. Mean values of pharmacokinetic parameters statistically compared using the two-tailed t-test.
Measured: Second and fourth 21 day cycle
Secondary outcomes (6)
Median Progression Free Survival
Measured: From the start of treatment until the time of death or progression, up to 10 years
Median Overall Survival
Measured: From the start of treatment until the time of death, up to 20 years
Change in Intraperitoneal VEGF levels
Measured: Cycle 4-6 day 8, day 1 of cycles 7-12 and 16-18 (cycle is 21 days)
Site of Cancer First Recurrence
Measured: At the time of first recurrence, assessed up to 10 years
Change in Plasma CA-125 Level
Measured: 1 Year
Clinical Response Rate
The number of participants that achieved a clinical response following treatment. Clinical response is defined as achieving a best overall response of a complete response (CR) or a partial response (PR).
- Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
- Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Richard Thomas Penson, Massachusetts General Hospital
- Investigators
- Richard T Penson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652119
- Sponsor's protocol ID
- 06-426
- Other IDs
- NCI-2010-00091
- Status last verified
- Aug 2020
- First submitted
- 31 Mar 2008
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin
- ClinicalTrials.gov ID
- NCT00652119
- Acronym / sponsor ID
- 06-426
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Keywords
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Carcinoma of Mullerian Origin, Paclitaxel, Taxol, Carboplatin, Paraplatin®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Genentech, Inc., National Cancer Institute (NCI)
- Study start
- Feb 2008 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2021 (estimated)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn about the safety and tolerability of paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian, primary peritoneal, or fallopian tube cancer.
Objectives:
Primary study goals:
To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in combination with IV Avastin To determine if Avastin influences the pharmacokinetics of IP administered chemotherapeutic agents
Secondary study goals:
To determine the systemic exposure to paclitaxel and carboplatin during initial and late cycles of IP dosing.
To collect overall survival (OS) and progression-free survival (PFS) To determine changes in IP VEGF levels To determine site of first recurrence Information on CA-125 response and clinical response will be descriptive as secondary goals of this study
Exploratory goal:
To estimate proportion of patients completing entire course of treatment
Detailed description
The Study Drugs:
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may cause them to die.
Avastin is designed to prevent or slow down the growth of cancer cells by blocking the effects of VEGF, a blood-vessel stimulating agent that plays an important role in the growth of both normal and abnormal blood vessels.
Intraperitoneal Port (IP) Placement:
If you are found eligible to take part in this study, you will need to have an IP port, called an intraperitoneal catheter tube, placed into the abdomen. The catheter will be used to give the paclitaxel and carboplatin directly into your abdomen. You may already have had this catheter placed at a previous surgery. If not, you will have a minor surgical procedure in the operating room to have it placed. You will be asked to sign a separate surgical consent form describing this procedure, the risks involved, and the steps for taking care of the catheter while it is in place.
Study Drug Administration:
You will receive up to 6 cycles of treatment with the study drugs. Each cycle is 21 days (3 weeks) long.
Cycle 1:
You will receive paclitaxel and carboplatin through a needle in your vein on Day 1. Paclitaxel is given first followed by carboplatin. Both drugs are given over 1 hour. On Days 8 and 15 you will only receive paclitaxel by vein. This infusion is also given over 1 hour.
Cycle 2:
On Day 1, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. This infusion takes 30-60 minutes. You will then receive paclitaxel through the IP port in your abdomen. When the paclitaxel infusion is complete, you will receive carboplatin through the IP port. Each infusion takes about 1 hour. After the chemotherapy infusions are complete, another 2-4 cups of normal saline will be infused through the port. This is done to help move the chemotherapy to all areas of your abdomen. You will be asked to change position frequently.
On Day 8, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. You will then receive paclitaxel through the IP port in your abdomen over 1 hour. While you are receiving paclitaxel through your IP port, you will also receive Avastin by vein. The first dose of Avastin will be given over 90 minutes. If you tolerate the first infusion well, the second infusion (given in Cycle 3) may be given over 60 minutes. If the 60-minute infusion is well-tolerated, all infusions after that may be given over 30 minutes. After the paclitaxel infusion is complete, you will receive another 2-4 cups of normal saline through the port. You will be asked to change position frequently.
On Day 15, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. You will then receive paclitaxel through the IP port in your abdomen. After the paclitaxel infusion is complete, you will receive another 2-4 cups of normal saline through the port. You will be asked to change position frequently.
Cycles 3-6:
On Day 1, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. You will receive paclitaxel through the IP catheter over 1 hour. After completing paclitaxel, you will receive carboplatin through the IP catheter over 1 hour. After these infusions are complete you will receive another 2-4 cups of normal saline through the port. You will be asked to change position frequently. While undergoing IP therapy with paclitaxel and carboplatin, you will also receive the second infusion of Avastin by vein. The length of this infusion will depend how well you tolerated the drug the first time it was given in Cycle 2.
On Days 8 and 15, about 2 cups of normal saline will be infused into your abdomen through the IP catheter. You will then receive paclitaxel through the IP port in your abdomen over 1 hour. After the paclitaxel infusion is complete, you will receive another 2-4 cups of normal saline through the port. You will be asked to change position frequently.
Before you receive paclitaxel and carboplatin, you will receive the drug dexamethasone by vein to help decrease the risk of study drug side effects. You may also receive other drugs (such as cimetidine and diphenhydramine) by vein to help with side effects, such as nausea and allergic reaction. The choice of which drugs to use is up to your doctor.
Study Visits:
On Day 1 of each cycle, the following tests and procedures will be performed:
- Your medical history will be recorded, including a list of any drugs you are taking.
- You will be asked how well you are able to perform your normal daily activities (performance status evaluation).
- You will have physical exam, measurement of your vital signs, and a neurological exam.
- You will be asked about any side effects you are experiencing.
- Blood (about 3 teaspoons) will be drawn for routine tests (this will be repeated on Days 8 and 15 of each cycle as well).
Blood (about 1 teaspoon) will be drawn to check your CA125 level before treatment starts in Cycle 1 and on Day 1 of Cycles 2, 4, and 6.
Before treatment starts in Cycle 1 and on Day 8 of Cycle 2 and Day 1 of Cycles 3-6, urine will be collected for routine tests.
On Days 1, 8, and 15 of Cycles 1, 2, and 4, blood (1 teaspoon each time) will be drawn 12 different times each day for pharmacokinetic (PK) testing. PK testing measures the amount of study drugs in the body at different time points. Blood (1 teaspoon each time) will also be drawn 1 time on Days 2 and 3 of Cycles 1, 2, and 4.
On Day 8 of Cycle 2 and Day 1 of Cycles 3, 4, and 6 before paclitaxel starts, you will have the levels of vascular endothelial growth factor (VEGF) in your abdominal fluid measured. VEGF is a protein that causes fluid build-up (ascites) in the abdomen. About 2 cups of normal saline will be infused through the IP port. You will be asked to change positions for about 15 minutes. Then about 3-4 tablespoons of the fluid will be removed from the port with a syringe. This shows how Avastin is affecting your abdominal fluid. You will also have blood (about 1 teaspoon) drawn to check the levels of VEGF in your blood.
Length of Study:
You may remain on this study for up to 6 cycles. You will be taken off study early if the disease gets worse or intolerable side effects occur.
End-of-Study Visit:
Once you are off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam.
- You will have a computed tomography (CT) scan.
- Blood (about 1 teaspoon) will be drawn to check your CA125 level.
Long-Term Follow-Up:
After your last study visit, you will be contacted about every 3 months from then on to check on how you are doing. You will return to the clinic or researchers will call you on the phone to ask you questions about how you are doing. Your doctor will tell you if any standard tests and procedures need to be performed.
This is an investigational study. Avastin, carboplatin, and paclitaxel are FDA approved and commercially available for the treatment of many types of cancer. At this time, the addition of Avastin to paclitaxel and carboplatin is being used to treat ovarian cancer in research only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel + Carboplatin + Avastin | Experimental | Drug: Paclitaxel, Drug: Carboplatin, Drug: AvastinPaclitaxel Cycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle. Carboplatin Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle. Avastin Cycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.
- Stage III or IV disease. Stage IV disease by virtue of pleural effusions is allowed but stage IV disease with visceral metastases e.g. lung, liver or abdominal wall is NOT ELIGIBLE. Please discuss any eligibility concerns directly with the P.I., Dr. Richard Penson.
- Patient must have undergone surgical staging and debulking with optimal (less than 1cm) cytoreduction.
- No significant intra-abdominal adhesions or other contraindication to IP port placement.
- Patients must give written informed consent.
Key exclusion criteria (25 listed)
- Visible disease on post-operative imaging (recognizing the limitations of postoperative CT scans due to postoperative changes there should be unequivocal CT evidence of residual disease greater than 1cm)
- ECOG performance status greater than or equal to 2
- Previous chemotherapy for the disease under study
- Suboptimal (greater than 1 cm residual disease) cytoreduction
- Creatinine greater than 1.5 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelAlso: TaxolCycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle. | Drug | Paclitaxel + Carboplatin + Avastin |
| CarboplatinAlso: Paraplatin®Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle. | Drug | Paclitaxel + Carboplatin + Avastin |
| AvastinAlso: Bevacizumab, Anti-VEGF monoclonal antibody, rhuMAb-VEGFCycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle. | Drug | Paclitaxel + Carboplatin + Avastin |
Primary outcome
Number of Patients Who Complete Entire Treatment Course
Time frame: Total treatment course = 6 cycles (1 cycle is 21 days)
Rate of completers estimated along with a 95% confidence interval to evaluate the tolerability of this regimen.
Systemic Exposure to Paclitaxel and Carboplatin
Time frame: Second and fourth 21 day cycle
Primary objective of pharmacokinetic studies is to determine whether rate and extent absorption of paclitaxel and carboplatin into systemic circulation when given by the intraperitoneal port (IP) route is influenced by concurrent administration of Avastin by vein. Sampling to define plasma concentration time courses of paclitaxel and carboplatin performed during second cycle without Avastin and fourth cycle of therapy with Avastin. Pharmacokinetic parameters and variables calculated according to standard equations. Concentration-time profiles of carboplatin and its metabolites analyzed by noncompartmental methods and/or nonlinear least squares regression. Mean values of pharmacokinetic parameters statistically compared using the two-tailed t-test.
6 secondary outcomes
Median Progression Free Survival
Time frame: From the start of treatment until the time of death or progression, up to 10 years
Median Overall Survival
Time frame: From the start of treatment until the time of death, up to 20 years
Change in Intraperitoneal VEGF levels
Time frame: Cycle 4-6 day 8, day 1 of cycles 7-12 and 16-18 (cycle is 21 days)
Site of Cancer First Recurrence
Time frame: At the time of first recurrence, assessed up to 10 years
Change in Plasma CA-125 Level
Time frame: 1 Year
Clinical Response Rate
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
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Ovarian Cancer, Fallopian Tube Cancer
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Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Penson, MD principal investigator
Massachusetts General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paclitaxel, Carboplatin and Avastin in people with Ovarian Cancer and Peritoneal Cancer, run by Massachusetts General Hospital at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Complete Entire Treatment Course (time frame: Total treatment course = 6 cycles (1 cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.