Ovarian Cancer 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
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.
OBJECTIVES:
- 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.
;
Primary Purpose: Treatment
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