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Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer - Article


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Colon Cancer

Cholangiocarcinoma 




Clinical Trial: Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer

This study is no longer recruiting patients.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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--

--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

Study chairs or principal investigators

Timothy Maughan,  Study Chair,  Medical Research Council   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065216; MRC-CR06; EU-96049
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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November 28, 2009



Page Updated: October 15, 2009
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