NCT00059618

PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied.

Detailed description

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.

Conditions

• Ovarian Cancer
• Primary Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
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.
DRUG	Carboplatin	AUC 5 by vein administered over one hour Day 1 of 28 day cycle for 8 cycles.

Timeline

• Start date: 2003-04-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2003-04-30
• Last updated: 2012-08-02

Locations

1 site across 1 country: United States