Phase I Study of Oral Capecitabine (Xeloda) as a Radiation Enhancer in Locally Unresectable, Residual, or Recurrent Colorectal Cancer Localized in the Pelvis
18 Years
N/A
Both
Cancer
Trial Information
Phase I Study of Oral Capecitabine (Xeloda) as a Radiation Enhancer in Locally Unresectable, Residual, or Recurrent Colorectal Cancer Localized in the Pelvis
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.
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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Charles Erlichman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000066811
NCT ID:
NCT00003704
Start Date:
April 1999
Completion Date:
Related Keywords:
- Cancer
- 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
- Colorectal Neoplasms
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| CentraCare Clinic | Saint Cloud, Minnesota 56303 |
| Altru Health Systems | Grand Forks, North Dakota 58201 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
