Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer

NCT00002893 | Unknown Phase 3

• 3 other identifiers: CDR0000065216MRC-CR06EU-96049
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Interventions

fluorouracil DRUG

leucovorin calcium DRUG

raltitrexed DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 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 PRIOR CONCURRENT THERAPY: No prior systemic chemotherapy except fluorouracil-based adjuvant regimen (e.g., QUASAR) At least 6 months since chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (1)

Velindre Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

Location

Related Publications (13)

• Hale JP, Cohen DR, Maughan TS, Stephens RJ. Costs and consequences of different chemotherapy regimens in metastatic colorectal cancer. Br J Cancer. 2002 Jun 5;86(11):1684-90. doi: 10.1038/sj.bjc.6600273.

  PMID: 12087450 BACKGROUND

• 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.

  BACKGROUND

• Maughan TS, James RD, Kerr DJ, Ledermann JA, McArdle C, Seymour MT, Cohen D, Hopwood P, Johnston C, Stephens RJ; British MRC Colorectal Cancer Working Party. Comparison of survival, palliation, and quality of life with three chemotherapy regimens in metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2002 May 4;359(9317):1555-63. doi: 10.1016/s0140-6736(02)08514-8.

  PMID: 12047964 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Fluorouracil; Leucovorin; raltitrexed

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Timothy Maughan, MD

  Velindre NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 13, 2004
• Study Start: June 1, 1995
• Last Updated: December 19, 2013

Record last verified: 2007-05

Locations

GB (1)