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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 |
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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: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00138177 History of Changes |
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 |
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Leucovorin Rectal Diseases Oxaliplatin Vitamins Anti-Inflammatory Agents, Non-Steroidal Analgesics Micronutrients Digestive System Neoplasms |
Vitamin B Complex Vorinostat Rectal Neoplasm Trace Elements Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Recurrence Calcium, Dietary Rectal Cancer Digestive System Diseases Analgesics, Non-Narcotic Fluorouracil Gastrointestinal Neoplasms Peripheral Nervous System Agents |
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Sensory System Agents |
Vitamins Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Vorinostat Enzyme Inhibitors Intestinal Diseases Protective Agents Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions |