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FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01747551
Recruitment Status : Completed
First Posted : December 11, 2012
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Peter C. Enzinger, MD, Dana-Farber Cancer Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions: Esophageal Cancer
Gastric Cancer
Interventions: Drug: Oxaliplatin
Drug: Leucovorin
Drug: Fluorouracil
Drug: Ziv-aflibercept

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled from January 2013 through April 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
mFOLFOX6 + Ziv-aflibercept Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
mFOLFOX6 + Placebo Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.

Participant Flow:   Overall Study
    mFOLFOX6 + Ziv-aflibercept   mFOLFOX6 + Placebo
STARTED   43   21 
COMPLETED   0   0 
NOT COMPLETED   43   21 
Progressive Disease                24                17 
Death                3                1 
Adverse Event                7                1 
Prolonged Treatment Delay                2                0 
Withdrawal by Subject                3                1 
Physician Decision                2                1 
Other                2                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis dataset is comprised of all randomized patients.

Reporting Groups
  Description
mFOLFOX6 + Ziv-aflibercept Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
mFOLFOX6 + Placebo Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
Total Total of all reporting groups

Baseline Measures
   mFOLFOX6 + Ziv-aflibercept   mFOLFOX6 + Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   21   64 
Age 
[Units: Years]
Median (Full Range)
 62 
 (32 to 83) 
 62 
 (40 to 79) 
 62 
 (21 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  14.0%      3  14.3%      9  14.1% 
Male      37  86.0%      18  85.7%      55  85.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   4.8%      1   1.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1   4.8%      1   1.6% 
White      41  95.3%      18  85.7%      59  92.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   4.7%      1   4.8%      3   4.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   43   21   64 


  Outcome Measures

1.  Primary:   6-month Progression-free Survival (PFS)   [ Time Frame: Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up was 6 months. ]

2.  Secondary:   Grade 4 Treatment-Related Toxicity Rate   [ Time Frame: Adverse events were collected each cycle on treatment. Patients received a median (range) treatment duration (months) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively. ]

3.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patients received a median (range) treatment duration (m) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively. ]

4.  Secondary:   Duration of Objective Response   [ Time Frame: Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up (months) median (range) was 14.5 (1.1-49.8) and 18.8 (0.6-49.8) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Enzinger
Organization: Dana-Farber Cancer Institute
phone: 617-632-3029



Responsible Party: Peter C. Enzinger, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01747551     History of Changes
Other Study ID Numbers: 12-401
First Submitted: December 5, 2012
First Posted: December 11, 2012
Results First Submitted: April 5, 2018
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018