RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or advanced colorectal cancer.

Condition	Treatment or Intervention	Phase
recurrent colon cancer adenocarcinoma of the rectum Stage IV rectal cancer recurrent rectal cancer stage IV colon cancer adenocarcinoma of the colon	Drug: R115777	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response rate to R115777 in patients with disseminated colorectal cancer who have been previously treated for advanced disease. II. Assess the time to treatment failure and survival of these patients with this treatment regimen. III. Determine the frequency and severity of toxicities of this regimen in these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral R115777 twice daily on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-7 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed advanced colorectal adenocarcinoma; Well differentiated OR Moderately well differentiated OR Poorly differentiated
• Distant metastases not surgically curable
• Measurable disease
• No prior treatment for disseminated disease
• No known brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: At least 4 weeks since prior adjuvant immunotherapy and recovered; No concurrent immunotherapy
• Chemotherapy: At least 4 weeks since prior adjuvant chemotherapy and recovered; No other concurrent chemotherapy
• Endocrine therapy: No concurrent hormonal therapy
• Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No more than 25% of total area of bone marrow irradiated; No concurrent radiotherapy
• Surgery: At least 2 weeks since prior surgery and recovered
• Other: No concurrent proton pump inhibitors; No other concurrent anticancer therapy

--Patient Characteristics--

• Age: 18 and over
• Performance status: Zubrod 0-1
• Life expectancy: Not specified
• Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT or SGPT no greater than 2.5 times ULN
• Renal: Creatinine no greater than 2.0 mg/dL
• Other: Not pregnant or nursing; Fertile patients must use effective contraception; Must be able to swallow or receive enteral medications through gastrostomy feeding tube; No intractable nausea or vomiting; No other prior malignancy for the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any adequately treated stage I or II cancer in complete remission

California
      University of California Davis Medical Center, Sacramento,  California,  95817,  United States
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States
      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States
Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States

Study chairs or principal investigators

Robert P. Whitehead,  Study Chair,  Southwest Oncology Group   

Study ID Numbers:  CDR0000067847; SWOG-S9923
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005833
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08