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Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

Primary Purpose

Colorectal Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capecitabine
Thalidomide
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Adenocarcinoma focused on measuring capecitabine, thalidomide, colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage IV (metastatic) disease Measurable tumor Serum creatinine < 1.5 mg/dl Total bilirubin < 2.0 mg/dl AST < 5 x ULN ANC > 1,500/mm3 Platelets > 100,000/mm3 Hemoglobin > 9.0 gm/dl Must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. At least 3 weeks must have passed since the last chemotherapy treatment 18 years of age or older ECOG performance status of less than or equal to 2 Life expectancy of greater than 12 weeks Exclusion Criteria: Prior treatment with mitomycin C or nitrosourea compounds Prior treatment with capecitabine or thalidomide Clinically apparent central nervous system metastases or carcinomatous meningitis Peripheral neuropathy of grade 2 or greater severity Myocardial infarction in the past 6 months Major surgery in the past 2 weeks Uncontrolled serious medical or psychiatric illness Pregnant or lactating women Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Known allergy to 5-FU

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer.

Secondary Outcome Measures

To evaluate the safety of capecitabine and thalidomide in this patient population.

Full Information

First Posted
September 9, 2005
Last Updated
December 20, 2007
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00165217
Brief Title
Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
Official Title
A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to collect information about the antitumor activity and the safety of capecitabine and thalidomide in patients with colorectal cancer.
Detailed Description
Patients will take capecitabine orally twice a day for two weeks followed by a one week break period. These three week cycles will continue as long as the patient continues to benefit from the the therapy and does not experience intolerable side effects. Thalidomide will be taken orally once daily in the evening. Each week teh daily dose of the medication will be increased by 100mg as long as the patient is not experiencing any moderate to severe side effects. The dose will be increased in this manner until the daily dose is 600mg. If side effects do develop, the dose will either be held constant or decreased until the side effects resolve. If the side effects do not resolve, treatment will be stopped. Before starting treatment and periodically throughout the study, a physical exam, routine blood tests, scans and x-rays will be done to monitor the body's response to the treatment. For women patients, pregnancy tests will be performed every 3 weeks while on therapy. Scans and x-rays will be performed every 9 weeks (after every 3 cycles of treatment) to follow the effects of the study drugs on the tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenocarcinoma
Keywords
capecitabine, thalidomide, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer.
Secondary Outcome Measure Information:
Title
To evaluate the safety of capecitabine and thalidomide in this patient population.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage IV (metastatic) disease Measurable tumor Serum creatinine < 1.5 mg/dl Total bilirubin < 2.0 mg/dl AST < 5 x ULN ANC > 1,500/mm3 Platelets > 100,000/mm3 Hemoglobin > 9.0 gm/dl Must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. At least 3 weeks must have passed since the last chemotherapy treatment 18 years of age or older ECOG performance status of less than or equal to 2 Life expectancy of greater than 12 weeks Exclusion Criteria: Prior treatment with mitomycin C or nitrosourea compounds Prior treatment with capecitabine or thalidomide Clinically apparent central nervous system metastases or carcinomatous meningitis Peripheral neuropathy of grade 2 or greater severity Myocardial infarction in the past 6 months Major surgery in the past 2 weeks Uncontrolled serious medical or psychiatric illness Pregnant or lactating women Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Known allergy to 5-FU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles S. Fuchs, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

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