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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003690 |
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 I |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of flavopiridol and cisplatin (part 1), followed by a dose-escalation study of carboplatin (part 2).
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.
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.
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
No CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study ID Numbers: | CDR0000066793, MAYO-950101, NCI-T97-0032 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003690 |
Health Authority: | United States: Federal Government |
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 |
Prostatic Diseases Skin Diseases Genital Neoplasms, Male Breast Neoplasms Urogenital Neoplasms Carboplatin Genital Diseases, Male Recurrence Melanoma Neuroendocrine Tumors |
Flavopiridol Neuroectodermal Tumors Cisplatin Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Prostatic Neoplasms Breast Diseases |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Nevi and Melanomas Growth Inhibitors |