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SWOG-S9635 Fluorouracil Plus Ethynyluracil in Advanced Colorectal Cancer Not Responded to Fluorouracil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003254
Recruitment Status : Completed
First Posted : June 16, 2004
Last Update Posted : March 8, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ethynyluracil may help fluorouracil kill more cancer cells by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus ethynyluracil in treating patients with advanced colorectal cancer that has not responded to fluorouracil.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: ethynyluracil Drug: fluorouracil Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer
Study Start Date : April 1998
Actual Primary Completion Date : November 2002
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 776C85 + 5-FU
776C85, 10mg/m2/dose, PO, Days 1-28 (BID), q 5 wk; 5-FU, 1.0mg/m2/dose, PO, Days 1-28 (BID), q 5 wk.
Drug: ethynyluracil
10mg/m2/dose, PO, Days 1-28, q 5wk
Other Name: 776C85

Drug: fluorouracil
1.0mg/m2/dose, PO, Days 1-28 BID, q 5wk
Other Name: 5-FU

Primary Outcome Measures :
  1. Confirmed Response Rate [ Time Frame: Once every 10 weeks until off treatment ]
    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.

Secondary Outcome Measures :
  1. Progression and Survival [ Time Frame: Once every 10 weeks until progression ]
    To assess time to progression and survival in this group of patients.

  2. Toxicities [ Time Frame: Once each week during treatment ]
    To assess the frequency and severity of toxicities associated with this treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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 chemotherapy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003254

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Cynthia G. Leichman, MD Albany Medical College
Publications of Results:
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Responsible Party: Southwest Oncology Group Identifier: NCT00003254    
Other Study ID Numbers: CDR0000066138
S9635 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2004    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Keywords provided by Southwest Oncology Group:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors