Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer
NCT ID: NCT00002801
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
1996-04-30
2009-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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leucovorin calcium
tegafur-uracil
radiation therapy
Eligibility Criteria
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Inclusion Criteria
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)
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Bruce D. Minsky, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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MSKCC-96025
Identifier Type: -
Identifier Source: secondary_id
BMS-MSKCC-96025
Identifier Type: -
Identifier Source: secondary_id
NCI-V96-0942
Identifier Type: -
Identifier Source: secondary_id
CDR0000064898
Identifier Type: -
Identifier Source: org_study_id