Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | United States | 85259-5404 |
| 2 | Beckman Research Institute, City of Hope | Los Angeles | California | United States | 91010 |
| 3 | Veterans Affairs Medical Center - Palo Alto | Palo Alto | California | United States | 94304 |
| 4 | Stanford University Medical Center | Stanford | California | United States | 94305-5408 |
| 5 | CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | United States | 80209-5031 |
| 6 | CCOP - Christiana Care Health Services | Wilmington | Delaware | United States | 19899 |
| 7 | Walter Reed Army Medical Center | Washington | District of Columbia | United States | 20307-5000 |
| 8 | Veterans Affairs Medical Center - Gainsville | Gainesville | Florida | United States | 32608-1197 |
| 9 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
| 10 | Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida | United States | 33612 |
| 11 | CCOP - Evanston | Evanston | Illinois | United States | 60201 |
| 12 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61602 |
| 13 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 14 | Indiana University Cancer Center | Indianapolis | Indiana | United States | 46202-5265 |
| 15 | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | United States | 46202 |
| 16 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309-1016 |
| 17 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 18 | Johns Hopkins Oncology Center | Baltimore | Maryland | United States | 21231 |
| 19 | New England Medical Center Hospital | Boston | Massachusetts | United States | 02111 |
| 20 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 21 | CCOP - Ann Arbor Regional | Ann Arbor | Michigan | United States | 48106 |
| 22 | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55417 |
| 23 | University of Minnesota Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 24 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 25 | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | United States | 07018-1095 |
| 26 | CCOP - Northern New Jersey | Hackensack | New Jersey | United States | 07601 |
| 27 | Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly | New Jersey | United States | 08060 |
| 28 | Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | United States | 11209 |
| 29 | NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York | United States | 10016 |
| 30 | University of Rochester Cancer Center | Rochester | New York | United States | 14642 |
| 31 | CCOP - Merit Care Hospital | Fargo | North Dakota | United States | 58122 |
| 32 | Veterans Affairs Medical Center - Cleveland | Cleveland | Ohio | United States | 44106 |
| 33 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
| 34 | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | United States | 43623-3456 |
| 35 | CCOP - Sooner State | Tulsa | Oklahoma | United States | 74136 |
| 36 | CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | United States | 17822-2001 |
| 37 | Hahnemann University Hospital | Philadelphia | Pennsylvania | United States | 19102-1192 |
| 38 | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
| 39 | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | United States | 19107 |
| 40 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 41 | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | United States | 15213 |
| 42 | Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania | United States | 15240 |
| 43 | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | United States | 57105-1080 |
| 44 | Veterans Affairs Medical Center - Nashville | Nashville | Tennessee | United States | 37212 |
| 45 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
| 46 | Veterans Affairs Medical Center - Madison | Madison | Wisconsin | United States | 53705 |
| 47 | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792 |
| 48 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 49 | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | United States | 53295 |
| 50 | MBCCOP - San Juan | San Juan | Puerto Rico | 00927-5800 | |
| 51 | Veterans Affairs Medical Center - San Juan | San Juan | Puerto Rico | 00927-5800 |
Sponsors and Collaborators
- Eastern Cooperative Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Howard S. Hochster, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000067511
- E-1299