Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Not specified MRC-CR06 EU-96049, NCT00002893

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.

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

Expected Enrollment

A total of 900 patients will be entered.

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.

Maughan TS, James RD, Kerr DJ, et al.: Comparison of survival, palliation, and quality of life with three chemotherapy regimens in metastatic colorectal cancer: a multicentre randomised trial. Lancet 359 (9317): 1555-63, 2002.[PUBMED Abstract]

Maughan T: Continous versus intermittent chemotherapy for advanced colorectal cancer: preliminary results of the MRC CR06b randomised trial. [Abstract] Br J Cancer 85 (suppl 1): A-CT1, 1, 2001.

Maughan TS, James RD, Kerr DJ, et al.: Continous vs intermittant chemotherapy for advanced colorectal cancer: preliminary results of the MRC Cr06b randomised trial. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-498, 2001.

Maughan TS, James RJ, Kerr DJ, et al.: Continous versus intermittent chemotherapy for advanced colorectal cancer: preliminary results of the MRC CR06B randomised trial. [Abstract] Eur J Cancer 37 (suppl 6): A-1001, s271, 2001.

Maughan T, James R, Kerr D, et al.: Excess treatment related deaths and impaired quality of life show raltitrexed is inferior to infusional 5FU regimens in the palliative chemotherapy of advanced colorectal cancer (CRC): final analysis of the MRC CR06. [Abstract] Ann Oncol 11 (suppl 4): A-185o, 43, 2000.

Lederman JA, Maughan TS, James RD, et al.: Preliminary results of a multicentre randomised trial comparing 3 chemotherapy regimens (de Gramont, Lokich and Raltitrexed) in metastatic colorectal cancer. [Abstract] Br J Cancer 80 (suppl 2): A-4.10, 20, 1999.

Maughan TS, James RD, Kerr D, et al.: Preliminary results of a multicentre randomised trial comparing three chemotherapy regimens in metastatic colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1007, 1999.

Maughan TS, Robbe IJ, Parsons C: Outcomes regarding patient needs in comparing infusional 5FU regimens versus raltitrexed in a MRC multicenter randomised trial of advanced colorectal cancer. [Abstract] Br J Cancer 80 (suppl 2): A-P112, 56, 1999.

Maughan TS, Stephens RJ, Hopwood P, et al.: The value of quality of life outcomes in comparing 3 chemotherapy regimens (de Gramont. Lokich and Raltitrexed) in a multicentre randomised trial of metastatic colorectal cancer. [Abstract] Br J Cancer 80 (suppl 2): A-P113, 57, 1999.

Maughan TS, Stephens RJ, Hopwood T, et al.: The value of quality of life in comparing 3 chemotherapy regimens (de Gramont, Lokich & Raltitrexed) in a multicentre randomised trial of metastatic colorectal cancer. [Abstract] Br J Cancer 80 (suppl 2): A-P113, 57, 1999.

Stephens RJ, Hopwood P, Johnston C, et al.: The value of quality of life (QL) outcomes in comparing 3 chemotherapy regimens (de Gramont, Lokich, and Raltitrexed) in a multicentre randomised trial of metastatic colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2220, 1999.

Hale JP, Cohen DR, Maughan TS, et al.: Costs and consequences of different chemotherapy regimens in metastatic colorectal cancer. Br J Cancer 86 (11): 1684-90, 2002.[PUBMED Abstract]

Hale JP, Cohen DR, Maughan TS, et al.: Comparative total societal costs of 3 alternative chemotherapy treatments for patients with advanced colorectal cancer. [Abstract] Br J Cancer 80 (suppl 2): A-P111, 56, 1999.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Timothy Maughan, MD, Protocol chair		Ph: 44-2920-316-904

Registry Information
Official Title		CHEMOTHERAPY CHOICES IN ADVANCED COLORECTAL CANCER: A RANDOMISED TRIAL COMPARING 2 DURATIONS AND 3 SYSTEMIC CHEMOTHERAPY REGIMENS IN THE PALLIATIVE TREATMENT OF ADVANCED COLORECTAL CANCER
Trial Start Date		1995-06-01
Registered in ClinicalTrials.gov		NCT00002893
Date Submitted to PDQ		1995-06-01
Information Last Verified		2007-05-14