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A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01490866
First Posted: December 13, 2011
Last Update Posted: January 12, 2017
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. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
Results First Submitted: September 21, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: Axitinib
Drug: Bevacizumab
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between January 2012 and January 2014, 70 patients with histologically or cytologically confirmed metastatic carcinoma of colon or rectum were enrolled and treated. The trial was conducted at 12 sites in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In this non-randomized open label trial, patients began treatment with FOLFOX/bevacizumab every 4 weeks for 16 weeks. Patients with objective response or stable disease began Axitinib maintenance therapy at week 17. Axitinib therapy continued until disease progression, unacceptable toxicity or did not meet any criteria for discontinuation.

Reporting Groups
  Description
FOLFOX/Bevacizumab and Axitinib

All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.

FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):

  • 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
  • Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
  • Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
  • Bevacizumab: 5 mg/kg on Days 1 and 15 by IV

Maintenance:

- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs.


Participant Flow for 2 periods

Period 1:   FOLFOX/Bevacizumab Treatment
    FOLFOX/Bevacizumab and Axitinib
STARTED   70 
COMPLETED   49 
NOT COMPLETED   21 
Disease Progression                6 
Adverse Event                6 
Withdrawal by Subject                5 
Protocol Violation                1 
Intercurrent illness                1 
Physician Decision                2 

Period 2:   Axitinib Maintenance Therapy
    FOLFOX/Bevacizumab and Axitinib
STARTED   49 
COMPLETED   0 [1] 
NOT COMPLETED   49 
Disease Progression                30 
Adverse Event                12 
Withdrawal by Subject                3 
Protocol Violation                2 
Intercurrent illness                2 
[1] No protocol defined endpoint to Axitinib maintenance treatment.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
FOLFOX/Bevacizumab and Axitinib

All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.

FOLFOX/bevacizumab:

  • 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
  • Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
  • Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
  • Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV

Maintenance:

- Axitinib: 5-mg tablets orally twice per day (PO BID)


Baseline Measures
   FOLFOX/Bevacizumab and Axitinib 
Overall Participants Analyzed 
[Units: Participants]
 70 
Age 
[Units: Years]
Median (Full Range)
 60 
 (36 to 90) 
Gender 
[Units: Participants]
Count of Participants
 
Female      34  48.6% 
Male      36  51.4% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   62 
Black/African American   6 
Asian   1 
Unknown   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: 24 months ]

2.  Secondary:   Objective Response Rate   [ Time Frame: every 8 weeks, assessed up to approximately 24 months ]

3.  Secondary:   Time To Progression (TTP)   [ Time Frame: every 8 weeks, assessed approximately up to 24 months ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: every 8 weeks until progression then every 3 months for up to 5 years. ]

5.  Secondary:   Frequency of Adverse Events as a Measure of Safety   [ Time Frame: Every 4 weeks plus 30 days during treatment and up to 5 years thereafter. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Charles H. Davis, RAC
Organization: SCRI Development Innovations
phone: 615 524-4341
e-mail: charles.davis2@scri-innovations.com



Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01490866     History of Changes
Other Study ID Numbers: SCRI GI 154
First Submitted: November 7, 2011
First Posted: December 13, 2011
Results First Submitted: September 21, 2016
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017