SWOG-S9635 Fluorouracil Plus Ethynyluracil in Advanced Colorectal Cancer Not Responded to Fluorouracil
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|ClinicalTrials.gov Identifier: NCT00003254|
Recruitment Status : Completed
First Posted : June 16, 2004
Last Update Posted : March 8, 2012
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
10mg/m2/dose, PO, Days 1-28, q 5wk
Other Name: 776C85
1.0mg/m2/dose, PO, Days 1-28 BID, q 5wk
Other Name: 5-FU
- 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.
- Progression and Survival [ Time Frame: Once every 10 weeks until progression ]To assess time to progression and survival in this group of patients.
- Toxicities [ Time Frame: Once each week during treatment ]To assess the frequency and severity of toxicities associated with this treatment.
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 ClinicalTrials.gov identifier (NCT number): NCT00003254
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|Study Chair:||Cynthia G. Leichman, MD||Albany Medical College|