Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Breast Cancer Melanoma (Skin) Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific |
| Intervention | Drug: alvocidib Drug: carboplatin Drug: cisplatin |
| Phase | Phase 1 |
| Sponsor | Mayo Clinic |
| Responsible Party | Mayo Clinic |
| ClinicalTrials.gov Identifier | NCT00003690 |
| First Received | November 1, 1999 |
| Last Updated | August 2, 2011 |
| Last verified | August 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 1, 1999 |
|---|---|
| Last Updated Date | August 2, 2011 |
| Start Date | December 1998 |
| Estimated Primary Completion Date | September 2003 |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors |
|---|---|
| Official Title | Phase I Study of Flavopiridol in Combination With Cisplatin in Patients With Advanced Malignancies |
| Brief 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. |
| Detailed 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. |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: alvocidib Drug: carboplatin Drug: cisplatin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 48 |
| Estimated Completion Date | September 2003 |
| Estimated Primary Completion Date | September 2003 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00003690 |
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| Other Study ID Numbers | CDR0000066793 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Mayo Clinic |
| Study Sponsor | Mayo Clinic |
| Collaborators | National Cancer Institute (NCI) |
| Investigators | Study Chair: Keith C. Bible, MD, PhD Mayo Clinic |
| Verification Date | August 2011 |
Locations[ + expand ][ + ]
| Mayo Clinic | Rochester, Minnesota, United States, 55905 |
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