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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006094 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of the rectum.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: fluorouracil Drug: oxaliplatin Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy in Locally Advanced Rectal Cancer |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study of oxaliplatin.
Patients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days 1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin 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. Once the MTD is determined, additional patients are treated at that dose level in the phase II portion of the study. (Phase I closed to accrual effective 03/27/2003).
Patients may undergo radical resection of rectal tumor within 4-6 weeks after completion of chemoradiotherapy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for phase I of the study (phase I closed to accrual effective 03/27/2003) and a total of 19 patients will be accrued for phase II of the study within 12-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven previously untreated adenocarcinoma of the rectum that begins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy
Locally advanced disease defined as any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | David P. Ryan, MD | Massachusetts General Hospital |
Study ID Numbers: | CDR0000068099, CALGB-89901 |
Study First Received: | August 3, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006094 |
Health Authority: | United States: Federal Government |
stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Rectal neoplasm |
Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Immunologic Factors Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |