Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002801
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: December 2009
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of fluorouracil-uracil and leucovorin plus radiation therapy in treating patients with colorectal cancer who have undergone surgery to remove the tumor.


Condition Intervention Phase
Colorectal Cancer
Drug: leucovorin calcium
Drug: tegafur-uracil
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: PHASE I TRIAL OF POST-OPERATIVE COMBINED ORAL UFT PLUS LEUCOVORIN AND RADIATION THERAPY FOR RECTAL CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: April 1996
Study Completion Date: December 2009
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of postoperative fluorouracil-uracil plus leucovorin calcium concurrently with radiotherapy in patients with colorectal cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the response of tumors in patients with measurable disease treated with this regimen.

OUTLINE: This is a dose-escalation study of fluorouracil-uracil (UFT). Beginning within 10 weeks after definitive surgery, patients receive oral UFT and oral leucovorin calcium (CF) 3 times a day on days 1-28. Treatment continues every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of the second course, patients undergo radiotherapy to the tumor bed and involved lymph nodes 5 days a week for 5 weeks, followed by boost radiotherapy to the primary tumor bed for 5-16 days. Patients receive 3 additional courses of UFT plus CF beginning 4 weeks after completion of radiotherapy or after recovery from the toxic effects of UFT, whichever occurs later. Patients who have measurable disease with ongoing response after the fifth course receive additional courses of UFT and CF. Cohorts of 3-6 patients receive escalating doses of UFT during the second course until the maximum tolerated dose (MTD) is determined. The MTD is defined as highest dose at which the minority of patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year and then at the discretion of the investigator.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of colorectal cancer for which postoperative radiotherapy to the pelvis is indicated

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 4,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT no greater than 1.25 times upper limit of normal (ULN) (no greater than 5 times ULN if elevation secondary to malignancy) Alkaline phosphatase no greater than 1.25 times ULN (no greater than 5 times ULN if elevation secondary to malignancy) Renal: Creatinine normal OR Creatinine clearance normal or greater than 60 mL/min Other: No medical or psychiatric condition that would preclude study No prior malignancy except: Appropriately treated localized epithelial skin or cervical cancer Remote history of other cured malignancy (at the discretion of the sponsor) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antineoplastic biological response modifiers Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the pelvis Surgery: See Disease Characteristics Other: No other concurrent investigational drugs No other concurrent antineoplastic therapy No concurrent halogenated antiviral agent (e.g., sorivudine)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002801

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Bruce D. Minsky, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002801     History of Changes
Other Study ID Numbers: CDR0000064898, MSKCC-96025, BMS-MSKCC-96025, NCI-V96-0942
Study First Received: November 1, 1999
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Tegafur
Leucovorin
Levoleucovorin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014