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NCT00588237 · ClinicalTrials.gov registry record · Phase 2
Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
A Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT00588237: Completed Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00588237 is a Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 42 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00588237, a Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test whether it is safe to treat your cancer with 3 drugs instead of 2 drugs. After surgery, your cancer is typically treated with 2 drugs called cisplatin and paclitaxel (also known as Taxol). Cisplatin is given through a port in your belly, and Taxol is given both through the belly port and through the vein (IV). Large clinical studies have shown that this treatment gives the best results for women with your cancer. This treatment, however, also causes many side effects, especially belly pain, nerve injury, lowering of the immune system, and infection risk. In the study you are being asked to join, the dose of Cisplatin will be lower in order to try to lessen these problems. This study will also test the safety of adding a 3rd drug called bevacizumab (also known as Avastin). This drug has been shown to shrink ovarian, peritoneal, or fallopian tube cancer in some patients who have advanced disease, despite having received prior treatment for their cancer. Therefore, it may also be effective in patients, like you, who have a new diagnosis. Unfortunately, Avastin can cause some dangerous side effects in women with advanced cancer. For instance, it can cause a hole in the intestines, and can increase the risk of blood clots and strokes. Avastin has not been given at the same time as IP therapy, so it is not known if this is a safe or effective combination. In this study, IV Avastin will be given in addition to IP cisplatin, IP Taxol, and IV Taxol, to patients like you who have not had any chemotherapy before. This study aims to find out what effects, good and/or bad, that this combination of drugs has on your body and on your type of cancer.
Primary Outcome
as determined by the GOG RECIST criteria
Conditions Studied
Interventions
- DRUG Paclitaxel,Cisplatin, Bevacizumab
Study Locations (1)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2006-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT00588237 record still lists
NCT00588237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which Paclitaxel,Cisplatin, Bevacizumab is the first listed.
NCT00588237 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00588237 about?
NCT00588237 is a clinical study titled "Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer". The purpose of this study is to test whether it is safe to treat your cancer with 3 drugs instead of 2 drugs. After surgery, your cancer is typically treated with 2 drugs called cisplatin and paclitaxel (also known as Taxol). Cisplatin is given through a port in your belly, and Taxol is given both t...
What is the current status of trial NCT00588237?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2006-08. Estimated completion is 2014-11.
What conditions does trial NCT00588237 study?
This clinical trial studies the following conditions: Ovarian Cancer, Fallopian Tube Cancer, Primary PERITONEUM.
What interventions are being tested in trial NCT00588237?
The interventions under investigation include: Paclitaxel,Cisplatin, Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT00588237?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00588237 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00588237's enrollment target sits among peer trials
42 224th of 322 higher than 97 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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