Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00004860
First received: March 7, 2000
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating elderly patients who have metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: leucovorin calcium
Drug: tegafur-uracil
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of ORZEL (UFT + Leucovorin) in Elderly (at Least 75 Years Old) Patients With Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Study Start Date: June 2000
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the response rate of elderly patients with metastatic colorectal cancer treated with fluorouracil-uracil and leucovorin calcium (Orzel). II. Evaluate the toxicity profile of this regimen in this patient population. III. Compare response rates obtained in this study with those observed in recent phase III studies in younger patients.

OUTLINE: Patients receive oral fluorouracil-uracil and oral leucovorin calcium (Orzel) every 8 hours for 28 days. Courses repeat every 35 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic colorectal adenocarcinoma Measurable disease

PATIENT CHARACTERISTICS: Age: 75 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST or ALT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: No serious infection No other serious underlying medical condition that would preclude protocol therapy No known hypersensitivity to fluorouracil-uracil or leucovorin calcium

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior adjuvant immunotherapy for colorectal cancer No concurrent immunotherapy Chemotherapy: At least 6 months since prior adjuvant chemotherapy for colorectal cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 6 months since prior adjuvant radiotherapy for colorectal cancer Prior radiotherapy for locally symptomatic disease allowed Surgery: Prior surgery allowed Other: No prior therapy for metastatic disease No other concurrent investigational drugs No concurrent halogenated antiviral agents (e.g., lodenosine, fialuridine, FMAU, emtricitabine, and sorivudine)

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004860

  Show 51 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Howard S. Hochster, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
Popa EC, Luo W, Hochster H, et al.: A phase II study of orzel (UFT+leucovorin) in elderly (=75 years old) patients with colorectal cancer: results of ECOG 1299. [Abstract] J Clin Oncol 23 (Suppl 16): A-3608, 273s, 2005.

ClinicalTrials.gov Identifier: NCT00004860     History of Changes
Other Study ID Numbers: CDR0000067511, E-1299
Study First Received: March 7, 2000
Last Updated: August 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Levoleucovorin
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014