Ovarian Cancer Clinical Trial

Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer

Summary

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.

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Full Description

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.

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.

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Eligibility 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

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

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)

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

51

Study ID:

NCT00003704

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 18 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

51

Study ID:

NCT00003704

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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