Know Cancer

forgot password

A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer

OBJECTIVES: I. Assess the confirmed response rate to fluorouracil (5-FU) plus ethynyluracil
(776C85) in patients with metastatic colorectal cancer that has been demonstrated to be
resistant to 5-FU. II. Assess time to progression and survival in this group of patients.
III. Assess the frequency and severity of toxicities associated with this treatment.

OUTLINE: Patients are stratified according to relapse while receiving adjuvant therapy
(relapse within 12 months of completing adjuvant therapy vs relapse while receiving adjuvant
therapy). Patients receive oral doses of ethynyluracil (776C85) and fluorouracil twice daily
for 28 days followed by 1 week of rest. Treatment continues every 5 weeks in the absence of
disease progression or unacceptable toxicity. Patients are followed every 3 months the first
year, every 4 months the second year, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 35-75 patients will be accrued for this study.

Inclusion Criteria

- Histologically or cytologically proven metastatic colorectal cancer

- Prior surgery required

- No prior treatment for metastatic disease

- Disease progression while on fluorouracil adjuvant therapy

- Bidimensionally measurable disease

- Age: Over 18

- Performance status: SWOG 0-2

- Hematopoietic: Platelet count at least 100,000/mm3, Absolute granulocyte count at
least 1,500/mm3

- Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT
no greater than 3 times ULN (no greater than 5 times ULN if liver involvement)

- Renal: Creatinine clearance at least 50 mL/min

- Other: Must be able to swallow and retain oral medications No nutritional support by
gastrostomy feeding tube or parenteral support No intractable vomiting or nausea

- Patients with history of prior malignancy must be currently disease free and off all
therapy for that malignancy

- Not pregnant or nursing Fertile patients must use effective contraception

- Biologic therapy: No concurrent immunotherapy Chemotherapy; At least 3 weeks since
prior chemotherapy and recovered; No concurrent flucytosine; No other concurrent

- Endocrine therapy: No concurrent hormonal therapy

- Radiotherapy: Prior adjuvant pelvic radiation or radiation to one area of recurrence
allowed At least 4 weeks since prior radiotherapy and recovered Total area of bone
marrow irradiation must not exceed 25% No concurrent radiotherapy

- Surgery: At least 2 weeks since prior surgery for colorectal cancer and recovered No
prior resection of the stomach or small intestine

- Other: No other concurrent anticancer therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed Response Rate

Outcome Description:

To assess the confirmed response rate to 5-fluorouracil plus 776C85 in patients with measurable, disseminated colorectal cancer that has been demonstrated to be resistant to 5-fluorouracil.

Outcome Time Frame:

Once every 10 weeks until off treatment

Safety Issue:


Principal Investigator

Cynthia G. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albany Medical College


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

October 2003

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms



Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
MBCCOP - University of South Alabama Mobile, Alabama  36688
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Beckman Research Institute, City of Hope Los Angeles, California  91010
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209