NCT01639131

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent.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.

Conditions

• Metastatic Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	intravenous gemcitabine 800mg/m2 on days 1 and 8
DRUG	Docetaxel	intravenous docetaxel 70mg/m2 on day 8 of each 21 day cycle
DRUG	Filgrastim or Pegfilgrastim	filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle

Timeline

• Start date: 2012-09-10
• Primary completion: 2016-10-03
• Completion: 2019-03-11
• First posted: 2012-07-12
• Last updated: 2022-08-10
• Results posted: 2022-08-10

Locations

3 sites across 2 countries: United States, Netherlands