Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

FIVC in Advanced Colorectal Cancer Patients With BRAF V600E Mutation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727763
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Zhan Wang, Shanghai Changzheng Hospital

Brief Summary:
This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Vemurafenib Drug: Cetuximab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center Clinical Study of FOLFIRI With Vemurafenib and Cetuximab in Advanced Colorectal Cancer Patients With BRAF V600E Mutation.
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FIVC group
Irinotecan 180mg/m2 iv gtt (14 days per course) leucovorin 400mg/m2 iv gtt (14 days per course) 5-fluorouracil 400mg/m2 iv (14 days per course) 5-fluorouracil 2400 mg/m2 46h (14 days per course) vemurafenib 960mg po bid cetuximab 500mg/m2 iv gtt (14 days per course)
Drug: Vemurafenib
960mg po bid
Other Name: PLX4032, RG7204

Drug: Cetuximab
500mg/m2 iv gtt (14 days per course)
Other Name: ERBITUX




Primary Outcome Measures :
  1. Objective Respone Rate(ORR) [ Time Frame: up to 55months ]
    Evaluation of tumor burden based on RECIST criteria every 4 cycles(each cycle is 14 days), ORR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response and partial response.


Secondary Outcome Measures :
  1. Early tumor shrinkage (ETS) rate [ Time Frame: up to 55months ]
    (ETS) rate is defined as 20% reduction in target lesions after the first 6 weeks of treatment (first tumor assessment)


Other Outcome Measures:
  1. Disease Control Rate (DCR) [ Time Frame: up to 55months ]
    Evaluation of tumor burden based on RECIST criteria every 4 cycles(each cycle is 14 days), and DCR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response, partial response and stable disease



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence;
  • Patients with BRAF V600E mutation and extended RAS wild type;
  • Patients have measurable lesions;
  • Patients are not available for targeted therapy or patients refuse to receive targeted therapy;
  • Age should be 18-25 years;
  • Performance status should be 0-2;

Exclusion Criteria:

  • Patients with RAS mutation type;
  • Patients with brain metastases;
  • Patients could not tolerate chemotherapy;
  • Patients have secondary primary tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727763


Contacts
Layout table for location contacts
Contact: Yuan-Sheng Zang, Prof +8613816584620 doctorzangys@163.com

Locations
Layout table for location information
China, Shanghai
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Zhan Wang, Prof.    +8613916229609    profoundamir@139.com   
Sponsors and Collaborators
Shanghai Changzheng Hospital
Investigators
Layout table for investigator information
Principal Investigator: Zhan Wang, Prof Shanghai Changzheng Hospital

Layout table for additonal information
Responsible Party: Zhan Wang, A single center clinical study of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation., Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT03727763     History of Changes
Other Study ID Numbers: FIVC
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhan Wang, Shanghai Changzheng Hospital:
FLOFIRI
vemurafenib
cetuximab
BRAF V600E mutation
Advanced Colorectal Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Vemurafenib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action