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Little Rock, Arkansas 72205

  • Colorectal Cancer

Purpose:

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.


Study summary:

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.


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 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


Study is Available At:


Original ID:

CDR0000066138


NCT ID:

NCT00003254


Secondary ID:

S9635


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Actual


Overall Contact Information

Official Name:Cynthia G. Leichman, MD
Study Chair
Albany Medical College

Study Dates

Start Date:April 1998
Completion Date:October 2003
Completion Type:Actual
Primary Completion Date:November 2002
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 6, 2012
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Confirmed Response Rate
Time Frame:Once every 10 weeks until off treatment
Safety Issues:False
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 Type:Secondary Outcome
Measure:Progression and Survival
Time Frame:Once every 10 weeks until progression
Safety Issues:False
Description:To assess time to progression and survival in this group of patients.
Outcome Type:Secondary Outcome
Measure:Toxicities
Time Frame:Once each week during treatment
Safety Issues:True
Description:To assess the frequency and severity of toxicities associated with this treatment.

Study Interventions

Intervention Type:Drug
Name:ethynyluracil
Description:10mg/m2/dose, PO, Days 1-28, q 5wk
Arm Name:776C85 + 5-FU
Other Name:776C85
Intervention Type:Drug
Name:fluorouracil
Description:1.0mg/m2/dose, PO, Days 1-28 BID, q 5wk
Arm Name:776C85 + 5-FU
Other Name:5-FU

Study Arms

Study Arm Type:Experimental
Arm Name:776C85 + 5-FU
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Leichman CG, Chansky K, Macdonald JS, Doukas MA, Budd GT, Giguere JK, Abbruzzese JL; Southwest Oncology Group. Biochemical modulation of 5-fluorouacil through dihydropyrimidine dehydrogenase inhibition: a Southwest Oncology Group phase II trial of eniluracil and 5-fluorouracil in advanced resistant colorectal cancer. Invest New Drugs. 2002 Nov;20(4):419-24.
PMID:12448660

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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