Cancer
Conditions
Keywords
stage III colon cancer, stage III rectal cancer, recurrent colon cancer, recurrent rectal cancer, recurrent anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, stage III cervical cancer, recurrent cervical cancer, stage III ovarian epithelial cancer, recurrent ovarian epithelial cancer, stage III vulvar cancer, recurrent vulvar cancer, stage III vaginal cancer, recurrent vaginal cancer, stage III penile cancer, recurrent penile cancer, stage III endometrial carcinoma, recurrent endometrial carcinoma, stage III bladder cancer, recurrent bladder cancer, stage III malignant testicular germ cell tumor, stage III prostate cancer, recurrent prostate cancer, recurrent malignant testicular germ cell tumor, ovarian stromal cancer, recurrent urethral cancer, distal urethral cancer, proximal urethral cancer, stage III ovarian germ cell tumor, recurrent ovarian germ cell tumor, fallopian tube cancer, primary peritoneal cavity cancer, stage III uterine sarcoma, recurrent uterine sarcoma, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma
Brief 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.
Detailed 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.
Interventions
DRUGcapecitabine
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | Up to 3 years |
Countries
Canada, United States
Outcome results
None listed