NCT01668680

Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma

Metronomic Chemotherapy With Anti-angiogenic Effect as Maintenance Treatment for Metastatic Colorectal Carcinoma Following Response to FOLFIRI+Bevacizumab: Clinical and Laboratory Studies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy which may be toxic +/- exhausting are candidates for an effective and more convenient maintenance treatment. Objectives: 1. To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab. 2. To discover predictive factors for response to this LDM regimen. Hypothesis: 1. The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy. 2. Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation of certain enzymes in the tumor may discover predictive factors of response to LDM chemotherapy in metastatic CRC patients.

Detailed description

At entry to the research protocol the up-till then administered treatment with Intra Venous FOLFIRI+BEVACIZUMAB will be stopped.Instead, the research oral treatment will be initiated to be taken daily on an ambulatory basis and under once monthly re-evaluation. If and when disease progresses the original FOLFIRI+BEVACIZUMAB treatment will be considered for re-institution.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	CAPECITABINE, CELECOXIB and METHOTREXATE	daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2012-08-20
• Last updated: 2015-07-08

Locations

1 site across 1 country: Israel