Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Melanoma (Skin) Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: alvocidib Drug: carboplatin Drug: cisplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study of Flavopiridol in Combination With Cisplatin in Patients With Advanced Malignancies |
| Estimated Enrollment: | 48 |
| Study Start Date: | December 1998 |
| Study Completion Date: | September 2003 |
| Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Keith C. Bible, M.D., Ph.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003690 History of Changes |
| Other Study ID Numbers: | CDR0000066793, U01CA069912, P30CA015083, 950101, 276-97 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mayo Clinic:
|
stage IV breast cancer recurrent breast cancer stage IV prostate cancer recurrent prostate cancer |
stage IV melanoma recurrent melanoma unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Breast Neoplasms Melanoma Prostatic Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Diseases Flavopiridol Cisplatin Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Growth Inhibitors Growth Substances Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013