Breast Cancer Clinical Trial
Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of flavopiridol plus cisplatin or carboplatin in treating patients who have advanced solid tumors.
Full Description
OBJECTIVES:
Determine the maximum tolerated dose (MTD) of flavopiridol and cisplatin in patients with advanced solid tumors. (Part 1)
Determine the MTD of carboplatin when combined with flavopiridol in another group of patients with advanced solid tumors. (Part 2)
Determine the toxic effects of these regimens in this patient population.
Determine the objective clinical response in patients treated with this regimen.
Determine the pharmacokinetics of these regimens in this patient population.
OUTLINE: This is a dose-escalation study of flavopiridol and cisplatin (part 1), followed by a dose-escalation study of carboplatin (part 2).
Part 1: Patients receive flavopiridol IV over 24 hours. Two weeks later, patients receive cisplatin IV over 2 hours immediately followed by flavopiridol IV over 24 hours. Treatment with cisplatin/flavopiridol continues every 3 weeks in the absence of unacceptable toxicity or disease progression.
Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. Cohorts of 3-6 patients receive escalating doses of flavopiridol and then cisplatin until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Part 2: Additional patients are accrued for part 2. Those patients receive carboplatin IV over 30 minutes immediately followed by flavopiridol IV over 24 hours. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of carboplatin until the MTD is determined. The MTD is defined as in part 1.
PROJECTED ACCRUAL: Approximately 36-48 patients will be accrued for this study within 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed unresectable advanced solid tumor for which no standard therapy exists that is potentially curative or definitely capable of extending life expectancy
Biopsy confirmation of recurrent tumors required, unless sole site of disease is inaccessible bony and/or pulmonary metastases
Eligible solid tumors include, but not are limited to, prostate cancer, breast cancer, or melanoma
No lymphoma
No CNS metastases
Patients with primary brain tumors are eligible if they are not receiving antiepileptic medication(s) but are receiving stable doses of corticosteroids
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age:
18 and over
Sex:
Not specified
Menopausal status:
Not specified
Performance status:
ECOG 0-2
Life expectancy:
See Disease Characteristics
At least 12 weeks
Hematopoietic:
WBC at least 3,500/mm^3
Absolute neutrophil count at least 1,700/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 8 g/dL
Hepatic:
Bilirubin within upper limit of normal (ULN)
AST and ALT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN
Renal:
Creatinine no greater than 1.5 times ULN
Cardiovascular:
No New York Heart Association class III or IV heart disease
No history of angina
Neurologic:
No grade 2 or greater peripheral neuropathy
No seizure disorder
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
More than 4 weeks since prior immunotherapy
More than 4 weeks since prior biologic therapy
No concurrent immunotherapy
Chemotherapy:
More than 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
No other concurrent chemotherapy
Endocrine therapy:
See Disease Characteristics
Radiotherapy:
More than 4 weeks since prior radiotherapy
No prior radiotherapy to more than 25% of bone marrow
No concurrent radiotherapy
Surgery:
See Disease Characteristics
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There is 1 Location for this study
Rochester Minnesota, 55905, United States
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