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Radiation Therapy With Capecitabine in Rectal Cancer

This study has been terminated.
(recruitment goals met)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00176787
First received: September 12, 2005
Last updated: December 28, 2007
Last verified: December 2007
History of Changes
  Purpose

This study will use an experimental combination of treatment with the drug Capecitabine and radiation therapy prior to an operation for removal of the patient's tumor. The drug Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal cancer.

This is a phase II clinical trial, which means that the physician will be studying the reactions of the patient's body and tumor to treatment with Capecitabine and radiation therapy. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. The study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur.

Preliminary human studies using Capecitabine and radiation therapy have produced encouraging results with acceptable side effects.


Condition Intervention Phase
Rectal Cancer
 Drug: Capecitabine
Procedure: Radiation
Procedure: Surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Objectives:
  • In patients with locally advanced rectal cancer treated with preoperative radiation and capecitabine chemotherapy to estimate:
  • a. the pathologic complete response rate
  • b. the clinical response rate
  • c. the proportion of patients converted to sphincter sparing surgery
  • clinical response rate [ Time Frame: 2 cycles ] [ Designated as safety issue: No ]
  • d. The quantitative and qualitative toxicities of the treatment approach
  • e. The relationship of intratumoral levels of thymidylate synthase, dipyrimidine dehydrogenase and thymidine phosphorylase determined immunohistochemically to response

Estimated Enrollment: 30
Study Start Date: October 2000
Study Completion Date: June 2007
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

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

Eligibility Criteria

  1. Histologic confirmation of adenocarcinoma of the rectum.
  2. The lesion must be located in the rectum. For purposes of this study, the lesion must be within 12 cm of the anus as measured by sigmoidoscopy.
  3. Patients must have indication of a locally advanced lesion defined for this study as tumor through the bowel wall (> T3) or involving regional lymph nodes (>N1). Clinical stage determination may be made by physical examination (for T4 lesions only), endoscopic ultrasound or CT scan of pelvis.
  4. Patients with metastatic disease are eligible provided operative intervention on primary site is anticipated.
  5. Patients must have adequate organ function defined as pretreatment leukocyte count > 3,000/ul, platelet count > 100,000/ul, serum creatinine < 2.0 mg/dl, serum bilirubin < 2 mg/dl. Note: Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min). In patients with calculated creatinine clearance of 30-50 ml/min capecitabine will begin at (-)1 level dose reduction (see section 6.3)
  6. Patients must be at least 18 years of age and have a Zubrod performance status of < 2 (see appendix 1.)
  7. Patients must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to the initiation of therapy.

Exclusion Criteria:

  1. Patients may not have received previous pelvic irradiation for any indication, or previous chemotherapy for cancer therapy within the preceding 6 months.
  2. Patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent.
  3. Pregnant or lactating women may not participate. Women/men of reproductive potential must agree to use an effective contraceptive method.
  4. Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome are not eligible.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176787

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Hoffmann-La Roche
Investigators
Principal Investigator: Mark Zalupski, M.D. University of Michigan Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00176787     History of Changes
Other Study ID Numbers: UMCC 0046
Study First Received: September 12, 2005
Last Updated: December 28, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
 Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013