Clinical Trial: Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Mi
Brief Summary: Determine the efficacy of combination Gemcitabine and Docetaxel chemotherapy in the treatment of metastatic colorectal cancer with CHFR and/or Microsatellite Instability (MSI) phenotype.
Detailed Summary:
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Current Primary Outcome: Response [ Time Frame: 4 years ]
Original Primary Outcome: Response [ Time Frame: 2.5 years ]
Current Secondary Outcome:
- Progression free survival [ Time Frame: 4 years ]Determine the progression free survival with gemcitabine and docetaxel combination therapy in the selected patient population
- Overall survival [ Time Frame: 4 years ]Determine the overall survival with gemcitabine and docetaxel combination therapy in the selected patient population
- CHFR methylation [ Time Frame: 4 years ]Assess CHFR methylation in circulating tumor DNA and compare to CHFR methylation observed in tumor tissue
- CHFR methylation II [ Time Frame: 4 years ]Assess changes in CHFR methylation in circulating tumor DNA over the time of therapy to determine if CHFR demethylation occurs as a predictor of progression
- Global methylation [ Time Frame: 4 years ]Analyze tumor tissue using a global methylation approach to develop a more robust predictive signature of treatment response
- Quality of life [ Time Frame: 4 years ]Evaluate changes in quality of life for patients treated with this regimen by serial measurements using the QLQ-C30 and QLQ-CR29 questionnaire.
Original Secondary Outcome:
- Progression free survival [ Time Frame: 4 years ]Determine the progression free survival with gemcitabine and docetaxel combination therapy in the selected patient population
- Overall survival [ Time Frame: 4 years ]Determine the overall survival with gemcitabine and docetaxel combination therapy in the selected patient population
- CHFR methylation [ Time Frame: 2.5 years ]Assess CHFR methylation in circulating tumor DNA and compare to CHFR methylation observed in tumor tissue
- CHFR methylation II [ Time Frame: 2.5 years ]Assess changes in CHFR methylation in circulating tumor DNA over the time of therapy to determine if CHFR demethylation occurs as a predictor of progression
- Global methylation [ Time Frame: 2.5 years ]Analyze tumor tissue using a global methylation approach to develop a more robust predictive signature of treatment response
- Quality of life [ Time Frame: 2.5 years ]Evaluate changes in quality of life for patients treated with this regimen by serial measurements using the QLQ-C30 and QLQ-CR29 questionnaire.
Information By: Sidney Kimmel Comprehensive Cancer Center
Dates:
Date Received: July 9, 2012
Date Started: August 2012
Date Completion:
Last Updated: December 14, 2016
Last Verified: December 2016