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A Phase II Study of ORZEL (UFT + Leucovorin) in Elderly (at Least 75 Years Old) Patients With Colorectal Cancer

Phase 2
75 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Phase II Study of ORZEL (UFT + Leucovorin) in Elderly (at Least 75 Years Old) Patients With Colorectal Cancer

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.

Inclusion 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

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)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • 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
  • Colorectal Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Stanford University Medical Center Stanford, California  94305-5408
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Johns Hopkins Oncology Center Baltimore, Maryland  21287
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Rochester Cancer Center Rochester, New York  14642
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Colorado Cancer Research Program, Inc. Denver, Colorado  80209-5031
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
New England Medical Center Hospital Boston, Massachusetts  02111
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Beckman Research Institute, City of Hope Los Angeles, California  91010
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County Mount Holly, New Jersey  08060
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
Veterans Affairs Medical Center - Cleveland Cleveland, Ohio  44106
Veterans Affairs Medical Center - Nashville Nashville, Tennessee  37212
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
CCOP - Sooner State Tulsa, Oklahoma  74136
Veterans Affairs Medical Center - Gainsville Gainesville, Florida  32608-1197