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Sponsored by: |
Sylvester Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00449137 |
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide may help fluorouracil and leucovorin work better by making tumor cells more sensitive to the drugs. Giving arsenic trioxide together with fluorouracil and leucovorin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide and fluorouracil when given together with leucovorin in treating patients with stage IV colorectal cancer that has relapsed or not responded to treatment.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: arsenic trioxide Drug: fluorouracil Drug: leucovorin calcium Procedure: fine-needle aspiration Procedure: laboratory biomarker analysis Procedure: protein expression analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of 5-FU (Plus Leucovorin) and Arsenic Trioxide for Patients With Refractory/Relapsed Metastatic Colorectal Carcinoma |
Estimated Enrollment: | 20 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of fluorouracil and arsenic trioxide.
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5, 8, 11, 15, 18, and 22 and fluorouracil IV over 24 hours and leucovorin calcium IV over 24 hours on days 8, 15, and 22. Treatment repeats every 5 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of fluorouracil and arsenic trioxide 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. At least 6 patients are treated at the MTD.
Patients undergo peripheral blood mononuclear cell (PBMC) collection and fine-needle tumor aspiration periodically to determine the effects of arsenic trioxide on thymidylate synthase expression in the tumor and in PBMCs.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 20 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:
Relapsed or refractory disease
PATIENT CHARACTERISTICS:
No cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center - Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com |
Study Chair: | Bach Ardalan, MD | Sylvester Cancer Center |
Study ID Numbers: | CDR0000533948, SCCC-2004162, SCCC-20050801 |
Study First Received: | March 15, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00449137 |
Health Authority: | Unspecified |
recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Arsenic trioxide Leucovorin Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Carcinoma Calcium, Dietary Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients |