Neoplasms

All Conditions

Symptoms and General Pathology

Adenocarcinoma

Microsatellite Instability

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Docetaxel

Lenograstim

Antimetabolites

Tubulin Modulators

Antimitotic Agents

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 Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent.

intravenous gemcitabine 800mg/m2 on days 1 and 8

intravenous docetaxel 70mg/m2 on day 8 of each 21 day cycle

filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle

Filgrastim or Pegfilgrastim

Nilofer Azad

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.

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 Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent.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

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

The Response Rate is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. PFS is defined as the number of months from the date of first dose of study drug to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.

Overall survival is the time from the start of first dose of study drug to death. OS will be measured from date of first dose of a study drug until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.

Gemcitabine and Docetaxel

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Nilofer Azad, MD

Patients were treated with 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.

Gemcitabine: intravenous gemcitabine 800mg/m2 on days 1 and 8

Docetaxel: intravenous docetaxel 70mg/m2 on day 8 of each 21 day cycle

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

Response Rate

Progression-free Survival (PFS)

Overall Survival With Gemcitabine and Docetaxel Combination Therapy

Patients received intravenous gemcitabine 800mg/m2 on days 1 and 8 and docetaxel 70mg/m2 on day 8 of each 21 day cycle. Patients received filgrastim (G-CSF) on days 9 through 15 or pegfilgrastim 6mg on day 9 or 10 of each cycle.

Gemcitabine: intravenous gemcitabine 800mg/m2 on days 1 and 8

Docetaxel: docetaxel 70mg/m2 on day 8 of each 21 day cycle

Filgrastim or Pegfilgrastim: filgrastim (G-CSF) on days 9 through 15 or pegfilgrastim 6mg on day 9 or 10 of each cycle

Spots Global Cancer Trial Database for filgrastim or pegfilgrastim