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Sponsors and Collaborators: |
UPMC Cancer Centers National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00287937 |
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Giving vorinostat together with paclitaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with paclitaxel and carboplatin in treating patients with advanced or refractory solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: carboplatin Drug: paclitaxel Drug: vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study Of Suberoylanilide Hydroxamic Acid (SAHA) (NSC 701852) in Combination With Paclitaxel /Carboplatin for Advanced and Refractory Solid Malignancies |
Estimated Enrollment: | 30 |
Study Start Date: | July 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of vorinostat (SAHA).
Patients receive oral SAHA once or twice daily on days 1-14* and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have stable disease after the completion of 6 courses may receive single-agent SAHA at the discretion of the treating physician.
NOTE: *During the first treatment course only, patients receive SAHA on days -4 to 10.
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. An additional 6-12 patients are treated at the MTD.
After completion of study treatment, patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No untreated brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No more than 2 prior chemotherapy regimens for advanced/metastatic disease
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 |
Study Chair: | Suresh Ramalingam, MD | UPMC Cancer Centers |
Study ID Numbers: | CDR0000454713, PCI-PHI-51, PCI-UPC-04-170, PCI-0504020, NCI-6922 |
Study First Received: | February 6, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00287937 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Anti-Inflammatory Agents Anticarcinogenic Agents Vorinostat Carboplatin Antimitotic Agents Paclitaxel Analgesics, Non-Narcotic |
Tubulin Modulators Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Antineoplastic Agents, Phytogenic |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vorinostat Mitosis Modulators Enzyme Inhibitors Carboplatin Antimitotic Agents Protective Agents Pharmacologic Actions |
Sensory System Agents Paclitaxel Analgesics, Non-Narcotic Therapeutic Uses Tubulin Modulators Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic |