Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00019747
- Brief Summary
RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the tumor. Giving thalidomide after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying surgery and thalidomide to see how well they work compared to surgery alone in treating patients with recurrent or metastatic colorectal cancer.
- Detailed Description
OBJECTIVES:
* Compare the disease-free survival probability in patients with previously resected recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs placebo.
* Compare the time to recurrence in patients treated with these regimens.
* Determine whether serum/plasma levels of vascular endothelial growth factor and basic fibroblast growth factor preresection and postresection correlate with tumor recurrence and determine if these levels, as well as carcinoembryonic antigen (CEA) measurements, aid in predicting time to recurrence in these patients.
* Determine the pharmacokinetics and toxicity of long-term thalidomide therapy in these patients.
* Determine whether patients receiving thalidomide develop measurable antiangiogenic activity.
* Measure the presence of circulating tumor cells preresection and postresection and determine if this type of analysis can be used to predict recurrence in this patient population.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to site of most recent lesion resection that rendered no evidence of disease (lung vs liver with no more than 3 lesions vs liver with more than 3 lesions vs lung and liver vs all other sites\[including sites that were both resected and ablated\]). Patients without evidence of residual disease are randomized to one of two treatment arms.
* Arm I: Patients receive oral thalidomide once daily.
* Arm II: Patients receive an oral placebo once daily. Treatment continues in both arms for 2 years in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for up to 3 years.
PROJECTED ACCRUAL: A total of 94 patients (47 per treatment arm) will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 - Thalidomide once daily adjuvant therapy Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose). Arm 2 - Placebo once daily Placebo Patients receive oral placebo once daily. Arm 2 - Placebo once daily adjuvant therapy Patients receive oral placebo once daily. Arm 1 - Thalidomide once daily thalidomide Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
- Primary Outcome Measures
Name Time Method Time to Progression 62 months Time to progression was measured from the on study date until the date of progression or last follow up. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST).Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Suburban Hospital Cancer Program
🇺🇸Bethesda, Maryland, United States
Center for Cancer Care at Goshen Health System
🇺🇸Goshen, Indiana, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
UPMC Cancer Center at UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States