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Trial record 65 of 723 for:    colon cancer AND 5-FU

An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02394834
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab Phase 3

Detailed Description:

The drug being tested in this study is called Panitumumab. This exploratory study will investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Tumor tissue samples obtained from the participants who enrolled in the safety/efficacy study of Panitumumab + mFOLFOX versus bevacizumab + mFOLFOX (PARADIGM Study: NCT02394795) and provided consent for this additional study will be used. Mutations, amplification and rearrangement of predefined tumor-associated genes will be investigated using DNA collected from tumor samples used for assessing RAS mutations and plasma free DNA collected before administration of cycle 1 and at the discontinuation of the protocol treatment in the main study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 757 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Phase III, Randomized, Controlled Study Comparing the Efficacy and Safety of mFOLFOX6 + Bevacizumab Therapy vs. mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Wild-type RAS(KRAS/NRAS) Unresectable Advanced or Recurrent Colorectal Cancer
Actual Study Start Date : May 29, 2015
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group P; mFOLFOX6 + panitumumab combination therapy
OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks
Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab
oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Active Comparator: Group B; mFOLFOX6 + bevacizumab combination therapy
OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks
Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to approximately 63 months ]
    OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 63 months ]
    PFS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. PFS is defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause.

  2. Response Rate (RR) [ Time Frame: Approximately 12 months ]
    RR obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. RR is defined as percentage of participants who achieve Complete Response (CR) and Partial Response (PR) as the best overall response per RECIST version 1.1.

  3. Duration of Response (DOR) [ Time Frame: Up to approximately 63 months ]
    DOR obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier.

  4. Percentage of Participants who Proceeded to Surgical Resection [ Time Frame: Up to approximately 63 month ]
    The outcome obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations.

  5. Percentage of Participants with Early Tumor Shrinkage [ Time Frame: Up to approximately 63 months ]
    The outcome obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations.

  6. Degree of the Maximum Tumor Shrinkage (Depth of Response) [ Time Frame: Up to approximately 63 months ]
    The outcome obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations.

  7. Evaluation of the Relationship of Each Biomarker in Plasma Free DNA and Tumor Samples at Baseline of the Main Study [ Time Frame: Up to approximately 63 months ]
  8. Evaluation of the Relationship between Each Biomarker in Plasma Free DNA at Baseline of the Main Study, and Efficacy Endpoints [ Time Frame: Up to approximately 63 months ]
  9. Evaluation of the Relationship between a Change in Each Biomarker in Plasma Free DNA at Baseline and the Discontinuation of the Protocol Treatment of the Main Study, and Efficacy Endpoints [ Time Frame: Up to approximately 63 months ]
  10. Evaluation of the Relationship between a Change in Each Biomarker in Tumor Tissue at Baseline and the Discontinuation of the Protocol Treatment of the Main Study, and Efficacy Endpoints [ Time Frame: Up to approximately 63 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study

Exclusion Criteria:

(1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study


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): NCT02394834


  Show 151 Study Locations
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02394834     History of Changes
Other Study ID Numbers: Panitumumab-4004
U1111-1167-3521 ( Other Identifier: WHO )
JapicCTI-152837 ( Registry Identifier: JapicCTI )
UMIN000016782 ( Registry Identifier: UMIN Clinical Trials Registry )
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Metastatic colorectal cancer, Panitumumab, mFOLFOX6, Bevacizumab
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Calcium, Dietary
Leucovorin
Bevacizumab
Panitumumab
Oxaliplatin
Fluorouracil
Calcium
Levoleucovorin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action