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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003004 |
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 combination chemotherapy with paclitaxel and cisplatin plus flavopiridol in treating patients who have refractory or recurrent solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: alvocidib Drug: cisplatin Drug: paclitaxel |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | An Open-Label, Non-Randomized Phase I Study of the Protein Kinase C Inhibitor Flavopiridol Administered in Combination With Paclitaxel in Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 73 |
| Study Start Date: | July 1997 |
OBJECTIVES: I. Determine the maximum tolerated dose of flavopiridol when administered in combination with paclitaxel and cisplatin in patients with refractory adult solid tumors. II. Investigate the clinical pharmacokinetics of intravenous flavopiridol when administered in combination with paclitaxel in these patients. III. Obtain preliminary data on the therapeutic activity of flavopiridol when administered in combination with paclitaxel in these patients. IV. Evaluate surrogate markers of activity such as inhibition of PKC or CDK1 in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive paclitaxel IV over 3 hours on day 1. On day 2, patients receive cisplatin IV over 20 minutes followed by a 24 hour infusion of flavopiridol. Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity. Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: Approximately 46-73 patients will be accrued for this study within 6 more months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven solid tumors that are refractory or recurrent -No CNS primary or metastatic disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky at least 60% Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: At least 6 months since prior cardiac arrhythmias, myocardial infarction, or congestive heart failure Other: Not pregnant or nursing Effective contraceptive method must be used for 2 months after study completion Not HIV positive No uncontrolled or serious infection No pre-existing grade 3 or greater neurotoxicity Must be mentally capable of understanding the explanation of the study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No presence of toxic effects from prior therapy
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000065571, MSKCC-9677A, NCI-T96-0091 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003004 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Pharmacologic Actions Neoplasms |
Cisplatin Radiation-Sensitizing Agents Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |
