A Phase II Trial of Oral Thalidomide as an Adjuvant Agent Following Metastasectomy in Patients With Recurrent Colorectal Cancer
- Compare the disease-free survival probability in patients with previously resected
recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs
- 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
- Determine whether patients receiving thalidomide develop measurable antiangiogenic
- 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time to Progression
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
Steven K. Libutti, MD
NCI - Surgery Branch
United States: Federal Government
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|Center for Cancer Care at Goshen Health System||Goshen, Indiana 46526|
|Suburban Hospital Cancer Program||Bethesda, Maryland 20817|
|UPMC Cancer Center at UPMC Presbyterian||Pittsburgh, Pennsylvania 15213|