A Phase II Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer
I. To determine the rate of complete response 2 years following the initiation of first line
5-FU (fluorouracil) based chemotherapy in patients with initially unresected metastatic
colorectal cancer who are then treated on the activating cancer stem cells (CSCs) from
dormancy and priming them for subsequent targeting (ADAPT) protocol.
I. To determine progression free survival (PFS), overall survival (OS), relapse free
survival (if complete response [CR]) from initiation of first line 5-FU based chemotherapy
based on intent to treat (ITT) analysis.
II. To determine the effects of v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras)
mutation status in response to ADAPT therapy.
Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance
ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or
upon achievement of resectable disease after radiation therapy.
RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive
capecitabine orally (PO) twice daily (BID) and celecoxib PO BID 5 days per week during
ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21.
Courses repeat every 21 days for up to 3 years in the absence of disease progression or
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 4 months for 2 years, and then every 6 months for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of CR, assessed according to CEA and CA 19-9 measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|