Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

Study Overview
=================
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.

Official Title
-----------------
A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

Conditions
-----------------
Colorectal Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Capecitabine
* Drug: Thalidomide


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine|nan|
|Drug: Thalidomide|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of capecitabine and thalidomide in this patient population. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capecitabine, thalidomide, colorectal cancer