drugset / Trial / NCT01668680

Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma

NCT01668680 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-09
Primary completion
2013-12
Completion
2014-12

Outcome

Outcome not reported

Stopped: “No satisfactory acrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule — Oral
Subject Celecoxib Other / unclassified — Oral
Subject Methotrexate Small molecule — Oral

Indications