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 ]

Determine the response rate of gemcitabine and docetaxel combination therapy for treatment of relapsed or refractory metastatic colorectal adenocarcinoma with methylation of CHFR and/or microsatellite instability


Original Primary Outcome: Response [ Time Frame: 2.5 years ]

Determine the response rate of gemcitabine and docetaxel combination therapy for treatment of relapsed or refractory metastatic colorectal adenocarcinoma with methylation of CHFR and/or microsatellite instability


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