Know Cancer

or
forgot password

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


Phase 2
75 Years
N/A
Not Enrolling
Both
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
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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000067511

NCT ID:

NCT00004860

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

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Rochester Cancer CenterRochester, New York  14642
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Medical College of WisconsinMilwaukee, Wisconsin  53226
Beckman Research Institute, City of HopeLos Angeles, California  91010
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Veterans Affairs Medical Center - ClevelandCleveland, Ohio  44106
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
CCOP - Sooner StateTulsa, Oklahoma  74136
Veterans Affairs Medical Center - GainsvilleGainesville, Florida  32608-1197