Ovarian CarcinomaPhase 2NCT00181701
Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin
A Phase 2 study testing Paclitaxel and Carboplatin in people with Ovarian Carcinoma, run by Massachusetts General Hospital.
Trial summary
The main purpose of this study is to determine the safety and tolerability of giving both paclitaxel and carboplatin in the abdominal cavity by looking at what effects (good and bad) this route of administration has on patients with ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- Paclitaxel and Carboplatin
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to May 2006
- Phase
- Phase 2
- 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
- Stage II or III disease
- Patient must have undergone surgical staging and debulking with optimal cytoreduction
- Able and willing to undergo a second look staging laparotomy
- 18 years of age or older
- Adequate bone marrow function with an Absolute Neutrophil Count (ANC) > 2,500 and platelets > 100,000/mm3
- ECOG performance status less than or equal to 2
Who cannot join
- Disease outside the abdominal cavity
- Stage IV disease, including abdominal wall, visceral and/or pleural involvement
- Previous chemotherapy for ovarian cancer
- Suboptimal cytoreduction
- Creatinine > 1.5 mg/dl
- History of recent Myocardial Infarction or congestive heart failure within 6 months of surgery
Show all 11Show fewer
- SGOT > 2x Upper Limit of Normal (ULN), bilirubin > 1.5 x ULN
- Colostomy or ileostomy
- Concurrent invasive malignancy
- Known hypersensitivity to E. coli derived products
- Active psychiatric or mental illness precluding informed consent
About this study
Official title: A Phase II Trial of Intraperitoneal Paclitaxel and Carboplatin Therapy in the Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin
The main purpose of this study is to determine the safety and tolerability of giving both paclitaxel and carboplatin in the abdominal cavity by looking at what effects (good and bad) this route of administration has on patients with ovarian cancer. Standard chemotherapy drugs are administered intravenously but a number of trials have shown that injecting drugs into the abdominal cavity, or intraperitoneally, have shown promising results.
Read the detailed description
Patients will have an intraperitoneal port placed at the time of their initial surgery or at a second procedure prior to cycle 2 of chemotherapy.
Patients will receive a total of 6 cycles of therapy as an outpatient. They will have 1 cycle of paclitaxel/carboplatin intravenously followed by 5 cycles of paclitaxel/carboplatin intraperitoneally. Chemotherapy treatment is given on days 1, 8, and 15 of each cycle. Each cycle is 21 days long.
To help reduce the chance of an allergic reaction, patients will also take decadron tablets orally before paclitaxel administration.
About 1 liter of standard salt solution will be injected through a catheter into the abdominal cavity with each treatment to help distribute the drugs throughout the abdominal cavity.
"Second-look" surgery (laparoscopy or laparotomy) will be performed 3-8 weeks after the last chemotherapy course (cycle 6) if the patient is in complete clinical remission. This surgery is done to see how effective the chemotherapy was.
Tests and procedures will be done throughout the treatment to see how the cancer is responding and to monitor for safety purposes. These tests and procedures include routine history and physical exam, neurological exam, and routine blood tests. As part of this study we will also be checking the amount of paclitaxel and carboplatin in the blood.
Participation in this study will last approximately 6 months as long as the treatment is well tolerated, there are no serious side effects and the disease has not progressed.
- Conditions
- Ovarian Carcinoma
- Being tested
- Paclitaxel, Carboplatin
- Keywords
- Ovarian cancer, Epithelial carcinoma of mullerian origin, Intraperitoneal paclitaxel, Intraperitoneal carboplatin, Primary peritoneal carcinoma, Tubal carcinoma
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
CarboplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally
Secondary outcomes (1)
To determine the efficacy of this regimen as defined by surgical response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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
- Dana-Farber Cancer Institute, Brigham and Women's Hospital
- 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
- NCT00181701
- Sponsor's protocol ID
- 04-100
- Status last verified
- Apr 2022
- First submitted
- 12 Sep 2005
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Intraperitoneal Paclitaxel and Carboplatin Therapy in the Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin
- ClinicalTrials.gov ID
- NCT00181701
- Acronym / sponsor ID
- 04-100
- Conditions
- Ovarian Carcinoma
- Keywords
- Ovarian cancer, Epithelial carcinoma of mullerian origin, Intraperitoneal paclitaxel, Intraperitoneal carboplatin, Primary peritoneal carcinoma, Tubal carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital
- Study start
- Oct 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 16 Sep 2005 (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 main purpose of this study is to determine the safety and tolerability of giving both paclitaxel and carboplatin in the abdominal cavity by looking at what effects (good and bad) this route of administration has on patients with ovarian cancer. Standard chemotherapy drugs are administered intravenously but a number of trials have shown that injecting drugs into the abdominal cavity, or intraperitoneally, have shown promising results.
Detailed description
Patients will have an intraperitoneal port placed at the time of their initial surgery or at a second procedure prior to cycle 2 of chemotherapy.
Patients will receive a total of 6 cycles of therapy as an outpatient. They will have 1 cycle of paclitaxel/carboplatin intravenously followed by 5 cycles of paclitaxel/carboplatin intraperitoneally. Chemotherapy treatment is given on days 1, 8, and 15 of each cycle. Each cycle is 21 days long.
To help reduce the chance of an allergic reaction, patients will also take decadron tablets orally before paclitaxel administration.
About 1 liter of standard salt solution will be injected through a catheter into the abdominal cavity with each treatment to help distribute the drugs throughout the abdominal cavity.
"Second-look" surgery (laparoscopy or laparotomy) will be performed 3-8 weeks after the last chemotherapy course (cycle 6) if the patient is in complete clinical remission. This surgery is done to see how effective the chemotherapy was.
Tests and procedures will be done throughout the treatment to see how the cancer is responding and to monitor for safety purposes. These tests and procedures include routine history and physical exam, neurological exam, and routine blood tests. As part of this study we will also be checking the amount of paclitaxel and carboplatin in the blood.
Participation in this study will last approximately 6 months as long as the treatment is well tolerated, there are no serious side effects and the disease has not progressed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma
- Stage II or III disease
- Patient must have undergone surgical staging and debulking with optimal cytoreduction
- Able and willing to undergo a second look staging laparotomy
- 18 years of age or older
Key exclusion criteria (11 listed)
- Disease outside the abdominal cavity
- Stage IV disease, including abdominal wall, visceral and/or pleural involvement
- Previous chemotherapy for ovarian cancer
- Suboptimal cytoreduction
- Creatinine > 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 |
|---|---|---|
| Paclitaxel | Drug | – |
| Carboplatin | Drug | – |
Primary outcome
To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally
1 secondary outcome
To determine the efficacy of this regimen as defined by surgical response rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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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.
Richard T Penson, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Carboplatin in people with Ovarian Carcinoma, run by Massachusetts General Hospital.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally. 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 14 Apr 2022.