Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib; Carboplatin

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