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

NCT00004860 | Completed Phase 2

• 2 other identifiers: CDR0000067511E-1299
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 51

Brief Summary

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.

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

leucovorin calcium DRUG

tegafur-uracil DRUG

Eligibility Criteria

• Age: 75 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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)

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

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (51)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Beckman Research Institute, City of Hope

Los Angeles, California, 91010, United States

Location

Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, 94304, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

CCOP - Colorado Cancer Research Program, Inc.

Denver, Colorado, 80209-5031, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Veterans Affairs Medical Center - Gainsville

Gainesville, Florida, 32608-1197, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Veterans Affairs Medical Center - Brooklyn

Brooklyn, New York, 11209, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Veterans Affairs Medical Center - Cleveland

Cleveland, Ohio, 44106, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Sooner State

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102-1192, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Veterans Affairs Medical Center - Pittsburgh

Pittsburgh, Pennsylvania, 15240, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57105-1080, United States

Location

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, 37212, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, 53705, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

MBCCOP - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Veterans Affairs Medical Center - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Related Publications (1)

• 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. doi: 10.1200/JCO.2006.10.4521.

  PMID: 18048821 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Leucovorin; Tegafur

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)

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

Study Officials

• Howard S. Hochster, MD

  NYU Langone Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: April 12, 2004
• Study Start: October 9, 2000
• Primary Completion: October 1, 2005
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (49); PR (2)