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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003254
First received: November 1, 1999
Last updated: March 6, 2012
Last verified: March 2012
  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.


Condition Intervention Phase
Colorectal Cancer
Drug: ethynyluracil
Drug: fluorouracil
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Confirmed Response Rate [ Time Frame: Once every 10 weeks until off treatment ] [ Designated as safety issue: No ]
    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:
  • Progression and Survival [ Time Frame: Once every 10 weeks until progression ] [ Designated as safety issue: No ]
    To assess time to progression and survival in this group of patients.

  • Toxicities [ Time Frame: Once each week during treatment ] [ Designated as safety issue: Yes ]
    To assess the frequency and severity of toxicities associated with this treatment.


Enrollment: 75
Study Start Date: April 1998
Study Completion Date: October 2003
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003254

  Show 86 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Cynthia G. Leichman, MD Albany Medical College
  More Information

Additional Information:
Publications:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00003254     History of Changes
Other Study ID Numbers: CDR0000066138, S9635, U10CA032102
Study First Received: November 1, 1999
Last Updated: March 6, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
5-ethynyluracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014