A Phase II Study Investigating Checkpoint With Forkhead and Ring Finger Domains (CHFR) Methylation Status In Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01715233
First received: October 24, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR.


Condition Intervention Phase
Metastatic Esophageal Cancer
Gastroesophageal Cancer
Gastric Cancer
Drug: mDCF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Investigating CHFR Methylation Status As A Biomarker For Taxane Sensitivity Using Modified Docetaxel, Cisplatin and 5 Flourouracil In Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR.


Secondary Outcome Measures:
  • CHFR methylaton Status. [ Time Frame: At Baseline. ] [ Designated as safety issue: No ]
    Estimate the proportion of advanced esophagogastric cancer patients that are positive for CHFR methylaton.

  • Overall survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    To determine overall survival.


Estimated Enrollment: 127
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
CHFR Methylated Group
Drug: mDCF
Modified Dose Docetaxel, Ciplatin, and 5FU.
Other Name: Modified DCF
Drug: mDCF
Modified Dose of Docetaxel, Cisplatin, and 5FU.
Other Name: Modified DCF
Active Comparator: Arm B
CHFR Unmethylated Group
Drug: mDCF
Modified Dose Docetaxel, Ciplatin, and 5FU.
Other Name: Modified DCF
Drug: mDCF
Modified Dose of Docetaxel, Cisplatin, and 5FU.
Other Name: Modified DCF

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have metastatic disease of the esophagus, gastroesophageal junction or stomach. Patients with locally recurrent disease who are not deemed eligible for radiation are also permitted.

Histological, cytologic or radiographic documentation of metastatic adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction or stomach. Radiologic, endoscopic, histologic or cytologic evidence of locally recurrent disease is also permitted.

Patients must be untreated with chemotherapy for metastatic or locally recurrent disease. Prior radiation therapy is permitted.

Patients must have measurable disease as per RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.

Age >18 years and ≤ 80 years.

ECOG performance status <2 (Karnofsky >60%, see Appendix A).

Life expectancy of greater than 3 months.

Patients must have normal organ and marrow function.

Patients must not have any of the following conditions:

Recent major surgery, hormonal therapy (other than replacement) or chemotherapy, within 4 weeks prior to entering the study or those who have not recovered from the adverse events of treatment.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy on this trial.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Patients who are receiving any investigational agents.

Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy used in the study.

Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort; these drugs induce CYP3A and may decrease levels of taxanes. 5-FU is a strong CYP2C9 inducer, and concomitant use with carvedilol, celocoxib, fosphenytoin, fluoxetine, phenytoin, warfarin and other CYP2C9 substrates should be used with caution.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant women are excluded from this study because chemotherapy has the potential for teratogenic or abortifacient effects.

HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapeutic agents. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715233

Contacts
Contact: Ronan J. Kelly, MD 410-287-0005 rkelly25@jhmi.edu
Contact: Charles P Raines 410-502-3696 craines1@jhmi.edu

Locations
United States, Maryland
SKCCC at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Charles P Raines, CRNP, MSN    410-502-3696    craines1@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Ronan J Kelly, MD, MBA SKCCC at Johns Hopkins
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01715233     History of Changes
Other Study ID Numbers: J1248
Study First Received: October 24, 2012
Last Updated: November 7, 2013
Health Authority: United States: The Johns Hopkins SKCCC CRO DSM Committee
United States: The JHMIRB
United States: Food and Drug Administration

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 28, 2014