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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003704
First received: November 1, 1999
Last updated: September 29, 2012
Last verified: December 2001
  Purpose

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 Intervention Phase
Cancer
Drug: capecitabine
Drug: chemotherapy
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Oral Capecitabine (Xeloda) as a Radiation Enhancer in Locally Unresectable, Residual, or Recurrent Colorectal Cancer Localized in the Pelvis

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 51
Study Start Date: April 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003704

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003704     History of Changes
Other Study ID Numbers: CDR0000066811, NCCTG-984652
Study First Received: November 1, 1999
Last Updated: September 29, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014