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Phase I Study of Oral Capecitabine (Xeloda) as a Radiation Enhancer in Locally Unresectable, Residual, or Recurrent Colorectal Cancer Localized in the Pelvis

Phase 1
18 Years
Open (Enrolling)

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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

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Charles Erlichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




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



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