Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

Colorectal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165217
• Other study ID #: 01-141
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: December 20, 2007
• Start date: November 2001
• Est. completion date: December 2005

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma

Intervention

Drug:
• Capecitabine

• Thalidomide

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer.
Secondary	To evaluate the safety of capecitabine and thalidomide in this patient population.