Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma

Metastatic Colorectal Adenocarcinoma Clinical Trial

Official title: A Multi-institutional Open Label, Trial Evaluating the Efficacy of Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma With Methylated CHFR and/or Microsatellite Instability Phenotype

Status Terminated

Clinical Trial Summary

The primary goal of the trail was to determine the efficacy of combining Gemcitabine and Docetaxel in treatment of metastatic colorectal cancer with CHFR and/or Microsatellite Instability (MSI) phenotype.

Clinical Trial Description

This was an open-label, multicenter, trial. Enrolled patients received an intravenous combination of gemcitabine 800 mg/m2 on days 1 and 8 and docetaxel 70 mg/m2 on day 8 of each 21-day cycle. Patients received filgrastim (granulocyte colony-stimulating factor [G-CSF]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle. Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent.

Patients underwent safety evaluations and monitoring for adverse events for each cycle.

Disease assessments (computed tomography or magnetic resonance imaging) were performed at baseline and then every 6 weeks. Response was evaluated according to the RECIST version1.1.

Patients who discontinue treatment will be monitored for overall survival. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Colorectal Adenocarcinoma

• NCT number: NCT01639131
• Study type: Interventional
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Status: Terminated
• Phase: Phase 2
• Start date: September 10, 2012
• Completion date: March 11, 2019