PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
|ClinicalTrials.gov Identifier: NCT00059618|
Recruitment Status : Completed
First Posted : April 30, 2003
Last Update Posted : August 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer||Drug: PS-341 (Bortezomib) Drug: Carboplatin||Phase 1|
Bortezomib is a drug that turns off certain genes and proteins inside the cancer cell that are responsible for cell growth. Researchers believe that when certain genes and proteins are turned off, the ability of the cancer cell to survive is decreased.
Before treatment starts, participants will have a complete checkup, blood tests, a urine test, a heart test, a chest x-ray, and either a CT scan or MRI scan. Women able to have children must have a negative blood pregnancy test within 14 days of beginning treatment. Blood tests and a complete checkup will also be done before each course of therapy and a month after treatment ends. Approximately 2-3 teaspoons of blood will be obtained for routine blood tests each time blood is drawn during this study.
Participants in this study will receive Bortezomib and carboplatin through a catheter (tube) placed in a vein. This is Day 1 of therapy. Bortezomib is given first (over 5 to 10 seconds) followed by carboplatin (over one hour). Bortezomib is then given alone on Days 4, 8, and 11. There is no treatment given on Days 12-28. One course of therapy is 28 days long and includes one dose of carboplatin and 4 doses of Bortezomib. All treatment is given on an outpatient basis at M. D. Anderson.
There are 4 different dose levels of Bortezomib being studied. The dose of Bortezomib that participants receive will depend on when they are enrolled. It will also depend on whether or not other participants had side effects from their treatment. Up to 6 patients could be treated at each dose.
Before each course of therapy, participants will have a physical exam and blood tests. A CT scan or MRI scan is repeated after Cycles 2 and 4 and at the end of treatment. Participants who have a partial or complete response (the tumor shrinks by more than 50% or disappears completely) will have a repeat CT or MRI 4 weeks later to confirm the response.
Participants may receive up to 8 courses of treatment. If the disease gets worse or if intolerable side effects occur, participants will be taken off study.
This is an investigational study. Bortezomib is approved for use by the FDA, in patients with multiple myeloma. Carboplatin is approved by the FDA, though its use with Bortezomib is experimental. A total of 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Evaluating the Safety and Tolerability of PS-341(Bortezomib)and Carboplatin in Patients With Platinum- and Taxane-Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
U.S. FDA Resources
PS-341 (Bortezomib) 0.8-1.5 mg/m^2 IV push + Carboplatin (AUC 5) IV on Day 1 of each cycle, then Bortezomib alone on Days 4, 8 and 11 in each 28 day cycle.
Drug: PS-341 (Bortezomib)
Starting dose 0.8 mg/m^2 given by vein over 5-10 seconds Day 1, 4, 8 and 11 of 28 day cycle for 8 cycles.
Other Names:Drug: Carboplatin
AUC 5 by vein administered over one hour Day 1 of 28 day cycle for 8 cycles.
Other Name: Paraplatin
- Maximum Tolerated Dose (MTD) of Bortezomib with Carboplatin Chemotherapy [ Time Frame: Assessed Day 21 of each 28 Day cycle, up to 4 cohorts for a total of 8 cycles ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059618
|United States, Texas|
|University of Texas M. D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Pedro T. Ramirez, MD||M.D. Anderson Cancer Center|