Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma

NCT00216424 | Terminated Phase 4

• 1 other identifier: XEL372
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week) during the course of radiation therapy is efficacious in locally advanced, non-metastatic rectosigmoid carcinoma and will improve resectability. The long-term working hypothesis is that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. In addition, it is expected that the simplicity of using an oral agent (capecitabine) will be associated with reduced cost and resource utilization.

Conditions

Colorectal Cancer

Keywords

Colon cancer; Rectal cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response and resectability of tumor following treatment with radiation and capecitabine (Xeloda).

Interventions

Capecitabine (Xeloda) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
• Age \>18 years
• Ambulatory outpatients (if applicable), with Karnofsky performance status of \>60
• Histologically or cytologically confirmed locally advanced nonmetastatic T3-4 N0-3 M0 carcinomas of the rectosigmoid.
• Surgical exploration without resection is permissible.
• Protocol Specific Laboratory Values as defined in section 4.2
• Has a negative serum pregnancy test within 7 days prior to start of therapy (female patients of childbearing potential).
• Have concomitant medications been reviewed with patient to address contraindicated medications described in section 7.8 and have precautions been taken as recommended for each drug? Includes Allopurinol, Cimetidine, Sorivudine and Brivudine, Anticoagulants, Phenytoin, and Laxatives.

You may not qualify if:

• Patients who fulfill any of the following criteria will be excluded:
• Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman or men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration
• Life expectancy \< 3 months.
• Serious, uncontrolled, concurrent infection(s).
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD deficiency.
• Completion of previous chemotherapy regimen \< four weeks prior to the start of study treatment, or with related toxicities unresolved prior to the start of study treatment.
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
• Clinically unstable cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
• Evidence of metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
• Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
• Major surgery within 4 weeks of the start of study treatment, without complete recovery (e.g., delayed wound healing).
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• Known, existing uncontrolled coagulopathy
• Any of the following laboratory values:

Sponsors & Collaborators

• James A. Haley Veterans Administration Hospital: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

James A. Haley Veterans Administration Hospital

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ismail Kazem, MD

  James A. Haley Veterans Administration Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2005
• Study Completion: January 1, 2007
• Last Updated: November 12, 2007

Record last verified: 2007-11

Locations

US (1)