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

This study has been completed.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004860
  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 II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

Drug Information available for:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Fluorouracil    Calcium gluconate    Tegafur    Uracil   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   June 2000

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

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

Show 51 study locations  Show 51 Study Locations

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Howard S. Hochster, MD     New York University School of Medicine    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Hochster HS, Luo W, Popa EC, Lyman BT, Mulcahy M, Beatty PA, Benson AB. Phase II study of uracil-tegafur with leucovorin in elderly (> or = 75 years old) patients with colorectal cancer: ECOG 1299. J Clin Oncol. 2007 Dec 1;25(34):5397-402.
 
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.
 

Study ID Numbers:   CDR0000067511, E-1299
First Received:   March 7, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004860
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Digestive System Neoplasms
Tegafur
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Vitamin B Complex
Neoplasms by Site
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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