Ovarian CancerPhase 2NCT00583622
Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients
A Phase 2 study testing Bevacizumab, Carboplatin and Docetaxel in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if bevacizumab, when given in combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan, cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin), can help to control ovarian cancer during a stem cell… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Bevacizumab, Carboplatin and Docetaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - <70.
- Patients with advanced ovarian, fallopian or primary peritoneal cancer in second or later complete remission, or untreated or refractory relapse, defined as relapse within 6 months of prior platinum treatment or lack of response to salvage treatment.
- No evidence of small bowel obstruction, as determined by CT scan of the abdomen and pelvis with oral and rectal contrast, within 30 days before the initiation of study treatment.
- Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >=60 ml/min, and urinary protein excretion <=500 mg/day.
- Adequate hepatic function, as defined by serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) <=3 * upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <=2 * ULN or considered not clinically significant.
- Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >=50% of predicted, corrected for volume or hemoglobin.
- Adequate cardiac function with left ventricular ejection fraction >=45%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status <2.
Who cannot join
- Failure to collect more than 3 * 10e6 CD34+ stem cells/kg body weight
- Patients with unresolved grade 3 or greater non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the principal investigator.
- Major surgery within 30 days before the initiation of study treatment
- Radiotherapy within 21 days prior to initiation of study treatment
- Patients with active Central Nervous System (CNS) disease.
- Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Principal Investigator and consider liver biopsy.
Show all 12Show fewer
- Uncontrolled infection, including HIV or HTLV-1 infection.
- Aspirin (> 325 mg/day) use within 10 days before initiation of study treatment.
- Ongoing uncontrolled hypertension (>140/90 mm Hg on medication).
- Non-healing wound or significant traumatic injury within 30 days before the initiation of study treatment
- Previous autologous or allogeneic stem cell transplant during the past year.
- Positive Beta HCG test in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Bevacizumab Combined With High-Dose Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Patients With Advanced Epithelial Ovarian Cancer
The goal of this clinical research study is to learn if bevacizumab, when given in combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan, cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin), can help to control ovarian cancer during a stem cell transplant. The safety of this drug combination will also be studied.
Read the detailed description
The Study Drugs:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
Carboplatin is designed to damage the DNA (the genetic material) of cancer cells, which may cause them to die.
Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die.
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by stopping tumor cells from repairing damage caused by these drugs.
Topotecan is designed to damage the DNA of cells, which may cause cancer cells to die.
Cyclophosphamide is designed to damage the DNA of cells, which may cause cancer cells to die.
Stem Cell Removal:
Before you begin receiving the study drugs, you will have apheresis done to collect some of your stem cells as a part of your standard of care. Apheresis is the process of removing part of the blood (such as platelets or white blood cells) from the body in order to remove certain elements, such as stem cells. Then, the rest of the blood is returned back to your body.
Apheresis will be done through a central venous catheter (CVC), usually in the chest. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain these procedures to you in more detail, and you will be required to sign a separate consent form for each procedure.
Your stem cells will be put back in your body after you finish receiving gemcitabine, docetaxel, melphalan, and carboplatin.
To prevent clotting, citrate (a blood thinner) will be added to the CVC during the apheresis procedure.
Study Drug Administration:
If you are found to be eligible to take part in this study, 2 weeks before your admission to the hospital (about 3 weeks before the stem cell transplant), you will receive bevacizumab through a the CVC over 45 minutes.
On Day 1 of your stay in the hospital, you will receive bevacizumab through the CVC over 45 minutes.
As part of standard mouth care, you will be asked to do mouthwashes 4 times a day (for 2 minutes each time) with caphosol (artificial saliva) followed by glutamine. Fifteen (15) minutes after each caphosol mouthwash, you will swish glutamine around in your mouth and gargle for 2 minutes, then spit it out. Do not swallow it.
On Day 2, through the CVC, you will receive gemcitabine over 3 hours and docetaxel over 2 hours. If you are allergic to carboplatin or older than 60 you will receive topotecan over 30 minutes.
On Day 3-5, through the CVC, you will receive gemcitabine over 3 hours, melphalan over 15 minutes, and carboplatin over 2 hours.
On Day 6, you will not receive any study drugs.
On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.
Starting the day after your stem cell transplant, as part of standard care, you will receive granulocyte-colony stimulating factor (G-CSF or filgrastim) as an injection under your skin daily, starting 1 day after the transplant, until your blood cell levels return to normal.
Starting 2 days after your transplant until 10 days after your transplant, you will receive methylprednisolone 2 times a day.
If you are allergic to carboplatin or older than 60:
On Day 1 of your stay in the hospital, you will receive bevacizumab through the CVC over 45 minutes.
On Day 2-4, through the CVC, you will receive cyclophosphamide over 2 hours and topotecan over 30 minutes. Each time you receive cyclophosphamide, you will also receive mesna to decrease the risk of bleeding in the bladder.
On Day 5-6, through the CVC, you will receive melphalan over 30 minutes and topotecan over 30 minutes.
On Day 7, you will not receive any study drugs.
On Day 8, you will receive the stem cells through the CVC over about 30-60 minutes.
Starting the day after your stem cell transplant, as part of standard care, you will receive G-CSF (filgrastim) as an injection under your skin daily, starting 1 day after the transplant, until your blood cell levels return to normal.
Study Visits:
At least once a week after the transplant, and then about 30, 60, and 100 days after your stem cell transplant, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- You will be checked for possible reactions to the treatment, including graft-versus-host disease (GVHD) and graft failure. Graft failure occurs when donor cells may not be able to grow and multiply in your body. If this happens, there will be a high risk of infections and/or bleeding.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check for tumor markers to check the status of the disease.
- Urine will be collected for routine tests.
- You will have a pelvic exam, if your doctor thinks it is needed.
- You will have an ECHO, if your doctor thinks it is needed.
- You will have a lung function test, if your doctor thinks it is needed.
- You will have CT scans of your chest, abdomen, and pelvis to check the status of the disease, if your doctor thinks it is needed.
- You will have a positron emission tomography - computed tomography (PET-CT) scan to check the status of the disease. A PET-CT is CT scan taken after a small amount of radioactive glucose (sugar) is injected into a vein to find cancer cells in the body.
These tests and procedures may be performed more often, if your doctor thinks it is needed.
End-of-Treatment Visit:
About 6 and 12 months after your stem cell transplant, then once a year after that (if your doctor thinks it is needed), the study visit tests and procedures listed above will be repeated.
Length of Study:
You will be off study after about 6 months. You will be taken off study early if the disease gets worse, if not enough stem cells can be collected, or if you experience any intolerable side effects.
Long-Term Follow-up:
If your doctor thinks it is necessary, you may have follow-up visits.
This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colorectal cancer. Gemcitabine, docetaxel, melphalan, and carboplatin are all FDA-approved and commercially available for the treatment of ovarian cancer. The use of bevacizumab with gemcitabine, docetaxel, melphalan, and carboplatin is investigational.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Ovarian Cancer
- Being tested
- Bevacizumab, Carboplatin, Docetaxel, Gemcitabine, Melphalan
- Keywords
- Ovarian Cancer, Epithelial Ovarian Cancer, Bevacizumab, Carboplatin, Gemcitabine, Docetaxel, Melphalan
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
5 mg/kg by vein daily over 90 minutes for 2 Days
CarboplatinDrug
Also called Paraplatin®
333 mg/m^2 by vein over 2 hours for 3 Days
DocetaxelDrug
Also called Taxotere
300 mg/m^2 by vein over 2 hours for 1 Day
GemcitabineDrug
Also called Gemzar®, Gemcitabine Hyrdrochloride
1,800 mg/m2 by vein over 3 hours for 4 Days
MelphalanDrug
50 mg/m^2 by vein over 15 minutes for 3 Days
Stem Cell TransplantProcedure or surgery
Also called SCT
- Stem Cell Removal via apheresis through a central venous catheter (CVC), usually in chest
- Stem Cell Replacement through CVC over about 30-60 minutes, Day 7 of treatment, following study drug regimen
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab + High-Dose Chemotherapy | Experimental | Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Docetaxel; Drug: Gemcitabine; Drug: Melphalan; Procedure: Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free (EF) Rate
Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.
Measured: Up to 6 Months
Secondary outcomes (1)
Participant Response
Number of participants evaluated using Response to Treatment in Solid Tumors (RECIST) with definitions of Complete Response (CR): disappearance of all target lesions; and, Partial Response: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Maintained Continued CR: participants who entered study in a CR and maintained CR post study treatment. Evaluations once a week till Day +30, then Days 30, 60, and 100 then at 6 months or until disease progression.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yago Nieto, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583622
- Sponsor's protocol ID
- 2007-0368
- Status last verified
- Apr 2013
- First submitted
- 20 Dec 2007
- Last updated
- 21 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab Combined With High-Dose Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Patients With Advanced Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00583622
- Acronym / sponsor ID
- 2007-0368
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Epithelial Ovarian Cancer, Bevacizumab, Carboplatin, Gemcitabine, Docetaxel, Melphalan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 21 May 2013
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 if bevacizumab, when given in combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan, cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin), can help to control ovarian cancer during a stem cell transplant. The safety of this drug combination will also be studied.
Detailed description
The Study Drugs:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
Carboplatin is designed to damage the DNA (the genetic material) of cancer cells, which may cause them to die.
Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die.
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by stopping tumor cells from repairing damage caused by these drugs.
Topotecan is designed to damage the DNA of cells, which may cause cancer cells to die.
Cyclophosphamide is designed to damage the DNA of cells, which may cause cancer cells to die.
Stem Cell Removal:
Before you begin receiving the study drugs, you will have apheresis done to collect some of your stem cells as a part of your standard of care. Apheresis is the process of removing part of the blood (such as platelets or white blood cells) from the body in order to remove certain elements, such as stem cells. Then, the rest of the blood is returned back to your body.
Apheresis will be done through a central venous catheter (CVC), usually in the chest. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain these procedures to you in more detail, and you will be required to sign a separate consent form for each procedure.
Your stem cells will be put back in your body after you finish receiving gemcitabine, docetaxel, melphalan, and carboplatin.
To prevent clotting, citrate (a blood thinner) will be added to the CVC during the apheresis procedure.
Study Drug Administration:
If you are found to be eligible to take part in this study, 2 weeks before your admission to the hospital (about 3 weeks before the stem cell transplant), you will receive bevacizumab through a the CVC over 45 minutes.
On Day 1 of your stay in the hospital, you will receive bevacizumab through the CVC over 45 minutes.
As part of standard mouth care, you will be asked to do mouthwashes 4 times a day (for 2 minutes each time) with caphosol (artificial saliva) followed by glutamine. Fifteen (15) minutes after each caphosol mouthwash, you will swish glutamine around in your mouth and gargle for 2 minutes, then spit it out. Do not swallow it.
On Day 2, through the CVC, you will receive gemcitabine over 3 hours and docetaxel over 2 hours. If you are allergic to carboplatin or older than 60 you will receive topotecan over 30 minutes.
On Day 3-5, through the CVC, you will receive gemcitabine over 3 hours, melphalan over 15 minutes, and carboplatin over 2 hours.
On Day 6, you will not receive any study drugs.
On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.
Starting the day after your stem cell transplant, as part of standard care, you will receive granulocyte-colony stimulating factor (G-CSF or filgrastim) as an injection under your skin daily, starting 1 day after the transplant, until your blood cell levels return to normal.
Starting 2 days after your transplant until 10 days after your transplant, you will receive methylprednisolone 2 times a day.
If you are allergic to carboplatin or older than 60:
On Day 1 of your stay in the hospital, you will receive bevacizumab through the CVC over 45 minutes.
On Day 2-4, through the CVC, you will receive cyclophosphamide over 2 hours and topotecan over 30 minutes. Each time you receive cyclophosphamide, you will also receive mesna to decrease the risk of bleeding in the bladder.
On Day 5-6, through the CVC, you will receive melphalan over 30 minutes and topotecan over 30 minutes.
On Day 7, you will not receive any study drugs.
On Day 8, you will receive the stem cells through the CVC over about 30-60 minutes.
Starting the day after your stem cell transplant, as part of standard care, you will receive G-CSF (filgrastim) as an injection under your skin daily, starting 1 day after the transplant, until your blood cell levels return to normal.
Study Visits:
At least once a week after the transplant, and then about 30, 60, and 100 days after your stem cell transplant, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- You will be checked for possible reactions to the treatment, including graft-versus-host disease (GVHD) and graft failure. Graft failure occurs when donor cells may not be able to grow and multiply in your body. If this happens, there will be a high risk of infections and/or bleeding.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check for tumor markers to check the status of the disease.
- Urine will be collected for routine tests.
- You will have a pelvic exam, if your doctor thinks it is needed.
- You will have an ECHO, if your doctor thinks it is needed.
- You will have a lung function test, if your doctor thinks it is needed.
- You will have CT scans of your chest, abdomen, and pelvis to check the status of the disease, if your doctor thinks it is needed.
- You will have a positron emission tomography - computed tomography (PET-CT) scan to check the status of the disease. A PET-CT is CT scan taken after a small amount of radioactive glucose (sugar) is injected into a vein to find cancer cells in the body.
These tests and procedures may be performed more often, if your doctor thinks it is needed.
End-of-Treatment Visit:
About 6 and 12 months after your stem cell transplant, then once a year after that (if your doctor thinks it is needed), the study visit tests and procedures listed above will be repeated.
Length of Study:
You will be off study after about 6 months. You will be taken off study early if the disease gets worse, if not enough stem cells can be collected, or if you experience any intolerable side effects.
Long-Term Follow-up:
If your doctor thinks it is necessary, you may have follow-up visits.
This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colorectal cancer. Gemcitabine, docetaxel, melphalan, and carboplatin are all FDA-approved and commercially available for the treatment of ovarian cancer. The use of bevacizumab with gemcitabine, docetaxel, melphalan, and carboplatin is investigational.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab + High-Dose Chemotherapy | Experimental | Drug: Bevacizumab, Drug: Carboplatin, Drug: Docetaxel, Drug: Gemcitabine, Drug: Melphalan, Procedure: Stem Cell TransplantBevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 - <70.
- Patients with advanced ovarian, fallopian or primary peritoneal cancer in second or later complete remission, or untreated or refractory relapse, defined as relapse within 6 months of prior platinum treatment or lack of response to salvage treatment.
- No evidence of small bowel obstruction, as determined by CT scan of the abdomen and pelvis with oral and rectal contrast, within 30 days before the initiation of study treatment.
- Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >=60 ml/min, and urinary protein excretion <=500 mg/day.
- Adequate hepatic function, as defined by serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) <=3 * upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <=2 * ULN or considered not clinically significant.
Key exclusion criteria (12 listed)
- Failure to collect more than 3 * 10e6 CD34+ stem cells/kg body weight
- Patients with unresolved grade 3 or greater non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the principal investigator.
- Major surgery within 30 days before the initiation of study treatment
- Radiotherapy within 21 days prior to initiation of study treatment
- Patients with active Central Nervous System (CNS) disease.
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 |
|---|---|---|
| BevacizumabAlso: Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF5 mg/kg by vein daily over 90 minutes for 2 Days | Drug | Bevacizumab + High-Dose Chemotherapy |
| CarboplatinAlso: Paraplatin®333 mg/m^2 by vein over 2 hours for 3 Days | Drug | Bevacizumab + High-Dose Chemotherapy |
| DocetaxelAlso: Taxotere300 mg/m^2 by vein over 2 hours for 1 Day | Drug | Bevacizumab + High-Dose Chemotherapy |
| GemcitabineAlso: Gemzar®, Gemcitabine Hyrdrochloride1,800 mg/m2 by vein over 3 hours for 4 Days | Drug | Bevacizumab + High-Dose Chemotherapy |
| Melphalan50 mg/m^2 by vein over 15 minutes for 3 Days | Drug | Bevacizumab + High-Dose Chemotherapy |
| Stem Cell TransplantAlso: SCT* Stem Cell Removal via apheresis through a central venous catheter (CVC), usually in chest * Stem Cell Replacement through CVC over about 30-60 minutes, Day 7 of treatment, following study drug regimen | Procedure or surgery | Bevacizumab + High-Dose Chemotherapy |
Primary outcome
Event-Free (EF) Rate
Time frame: Up to 6 Months
Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.
1 secondary outcome
Participant Response
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Yago Nieto, MD, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Carboplatin and Docetaxel in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Event-Free (EF) Rate (time frame: Up to 6 Months). 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 21 May 2013.