Colon Cancer |
Cholangiocarcinoma |
Clinical Trial: Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
This study is no longer recruiting patients.
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Purpose
RATIONALE: Palliative chemotherapy may help patients with advanced colorectal cancer live longer and more comfortably. PURPOSE: Randomized phase III trial to compare the effectiveness of and quality of life following three different palliative chemotherapy regimens in treating patients with advanced metastatic or recurrent colorectal cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| recurrent colon cancer stage III rectal cancer Stage IV rectal cancer adenocarcinoma of the rectum recurrent rectal cancer childhood gastrointestinal cancer stage III colon cancer stage IV colon cancer Quality of Life adenocarcinoma of the colon | Drug: fluorouracil Drug: leucovorin calcium Drug: raltitrexed | Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Colorectal Cancer; Digestive Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Leucovorin/Fluorouracil vs Continuous-Infusion Fluorouracil vs ICI D1694 as Palliative Therapy for Advanced Colorectal Cancer, with a Second Randomization in Stable and Responding Patients for Continued Chemotherapy vs Observation
Study start: June 1995
OBJECTIVES: I. Compare the survival and quality of life of patients with metastatic or recurrent colorectal cancer receiving palliative therapy with leucovorin/fluorouracil vs. continuous-infusion fluorouracil vs. ICI D1694. II. Compare the survival and quality of life of patients with stable or responding disease after 12 weeks of initial treatment randomized to receive 12 additional weeks of chemotherapy vs. no further treatment.
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomized to one of three treatment regimens. The first group receives leucovorin followed by fluorouracil every 14 days for a total of 6 courses. The second group receives continuous-infusion fluorouracil for 12 weeks. The third group receive ICI D1694 every 21 days for a total of 4 courses. Patients without progressive disease or excessive toxicity after 12 weeks of treatment are then randomized to receive continuing chemotherapy in 12 weekly cycles of their assigned chemotherapy or to proceed to observation with no further therapy, until evidence of disease progression. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 900 patients will be entered.
Eligibility
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically confirmed adenocarcinoma of the colon or rectum in one of the following categories: Locally advanced, metastatic, or recurrent disease suitable only for palliative chemotherapy
- Evaluable disease outside prior radiotherapy field
- Patients with disease confined to the liver are referred to protocol MRC-CR05
--Prior/Concurrent Therapy--
- No prior systemic chemotherapy except fluorouracil-based adjuvant regimen (e.g., QUASAR); At least 6 months since chemotherapy
--Patient Characteristics--
- Age: Not specified
- Performance status: WHO 0-2
- Life expectancy: Greater than 3 months
- Hematopoietic: WBC at least 4,000 ANC at least 2,000; Platelets at least 100,000
- Hepatic: Not specified
- Renal: Creatinine no greater than 1.25 times normal OR Creatinine clearance greater than 65 mL/min
- Cardiovascular: No uncontrolled heart failure; No uncontrolled angina
- Other: No uncontrolled medical illness (including infection); Able and willing to complete quality-of-life questionnaires; No prior or concurrent malignancy likely to interfere with protocol treatment or evaluation
Location Information
United Kingdom, Wales
Velindre Hospital, Cardiff, Wales, CF4 7XL, United Kingdom
Timothy Maughan, Study Chair, Medical Research Council
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002893
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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