RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable, residual, or recurrent colorectal cancer located in the pelvis.

Condition	Treatment or Intervention	Phase
Gastrointestinal Cancer Reproductive Cancers	Drug: capecitabine	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of oral capecitabine administered in combination with pelvic radiotherapy in patients with unresectable, residual, or locally recurrent cancer localized in the pelvis. II. Determine the tolerance of this regimen in these patients. III. Determine the preliminary evidence of therapeutic acticivity of this regimen in these patients.

PROTOCOL OUTLINE: This is a dose-escalation study of capecitabine. Patients receive oral capecitabine twice a day 7 days a week for 6 weeks with concurrent radiotherapy. Radiotherapy is initiated on the same day as the initiation of capecitabine and is administered 5 days a week for 5.5-6 weeks. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A maximum of 51 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed carcinoma located in the pelvis that is unresectable, incompletely resected, or locally recurrent; Must be biopsy-proven or have radiological progression
• All disease must be encompassable within standard pelvic radiotherapy fields
• No evidence of metastatic disease outside of the planned radiotherapy field

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy for metastatic cancer; At least 6 months since prior adjuvant chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; No prior radiotherapy
• Surgery: At least 21 days since prior laparotomy or laparoscopic procedure with or without resection
• Other: No concurrent sorivudine or chemically related analogues (e.g., brivudine)

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Not specified
• Renal: Creatinine clearance at least 30 mL/min
• Other: Must maintain adequate oral nutrition (i.e., at least 1200 calories estimated intake per day); No significant infection or other concurrent medical condition that would preclude study; No significant nausea or vomiting; No malabsorption secondary to short-gut syndrome, Crohn's disease, or sprue; No patients with more than 6 bowel movements per day or baseline no greater than grade 3 diarrhea for patients with colostomy; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      CentraCare Clinic, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
North Dakota
      Altru Health Systems, Grand Forks,  North Dakota,  58201,  United States
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States
Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada

Study chairs or principal investigators

Charles Erlichman,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000066811; NCCTG-984652
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003704
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08