Ovarian Cancer Clinical Trial
Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
Recurrent or progressive disease
Received at least 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease
May include high-dose therapy, consolidation, or extended therapy after surgical or non-surgical assessment
No brain metastases or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age:
Not specified
Performance status:
Karnofsky 70-100%
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 8.0 g/dL
Hepatic:
AST and ALT no greater than 2.5 times upper limit of normal
Bilirubin no greater than 1.8 mg/dL
Renal:
Creatinine no greater than 1.5 mg/dL
Cardiovascular:
LVEF greater than 50% by radionuclide ventriculogram or two-dimensional echocardiogram
No peripheral vascular disease requiring surgical management
No prior myocardial infarction
No congestive heart failure
No orthostatic hypotension
No acute ischemia or significant conduction abnormality (bifascicular block, defined as left anterior hemiblock with right bundle branch block, second or third degree AV blocks) as evidenced by electrocardiogram
No prior cerebrovascular event
Other:
No peripheral neuropathy grade 2 or greater
No other serious medical or psychiatric illness
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
See Disease Characteristics
No more than 2 prior regimens for recurrent disease, including 1 non-platinum containing regimen
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
Endocrine therapy:
At least 1 week since prior hormonal therapy directed at primary tumor
Concurrent hormone replacement therapy allowed
Radiotherapy:
Not specified
Surgery:
See Disease Characteristics
At least 2 weeks since prior major surgery
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New York New York, 10021, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.