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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00138177 |
RATIONALE: Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of suberoylanilide hydroxamic acid when given together with fluorouracil, leucovorin, and oxaliplatin in treating patients with progressive metastatic or unresectable colorectal cancer or solid tumor.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Drug: vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With 5-Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) in Patients With Advanced Colorectal Cancer or Other Solid Tumors |
Estimated Enrollment: | 54 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of suberoylanilide hydroxamic acid (SAHA).
Patients receive oral SAHA once or twice daily on days 1-3. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 4 followed by fluorouracil IV over 46 hours on days 4-5. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
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 dose-limiting toxicity. A total of 10 patients are treated at the MTD.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 54 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:
Histologically confirmed colorectal cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Marwan Fakih, MD 716-845-3362 marwan.fakih@roswellpark.org |
Study Chair: | Marwan Fakih, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000439445, RPCI-I 55305, NCI-6789 |
Study First Received: | August 29, 2005 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00138177 |
Health Authority: | Unspecified |
recurrent colon cancer stage III colon cancer stage IV colon cancer recurrent rectal cancer |
stage III rectal cancer stage IV rectal cancer unspecified adult solid tumor, protocol specific |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Vorinostat Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Antimetabolites Anti-Inflammatory Agents Anticarcinogenic Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Sensory System Agents Vitamins Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal |
Micronutrients Analgesics Vitamin B Complex Growth Substances Enzyme Inhibitors Immunosuppressive Agents Protective Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |