Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT00028912|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 26, 2011
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may help carboplatin kill more tumor cells by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with carboplatin in treating patients who have recurrent or progressive ovarian epithelial, primary peritoneal, or fallopian tube cancer.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: bortezomib Drug: carboplatin||Phase 1|
- Determine the maximum tolerated dose of bortezomib in combination with carboplatin in patients with recurrent or progressive ovarian epithelial, primary peritoneal, or fallopian tube cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacodynamics of this regimen in these patients by measurement of 20S proteasome inhibition in whole blood.
- Correlate toxicity with 20S proteasome inhibition in a whole blood assay in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive carboplatin IV over 30 minutes on days 1 and 8 followed by 1 week of rest during the first course of treatment. Beginning with the second course, patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 8 additional patients are accrued and treated at that dose.
PROJECTED ACCRUAL: A total of 3-32 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Trial of Bortezomib (NSC 681239, IND#58443) and Carboplatin in Recurrent or Progressive Epithelial Ovarian Cancer or Primary Peritoneal Cancer|
|Study Start Date :||November 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028912
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Carol Aghajanian, MD||Memorial Sloan Kettering Cancer Center|