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Trial record 1 of 1 for:    ml28442
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Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer (STEAM)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765582
First Posted: January 10, 2013
Last Update Posted: September 18, 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.
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: June 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Neoplasms
Interventions: Drug: 5-fluorouracil
Drug: bevacizumab
Drug: capecitabine
Drug: irinotecan
Drug: folinic acid
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
No text entered.

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
Arm A: Concurrent FOLFOXIRI + Bevacizumab Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
Arm B: Sequential FOLFOXIRI + Bevacizumab Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
Arm C: FOLFOX + Bevacizumab Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.

Participant Flow:   Overall Study
    Arm A: Concurrent FOLFOXIRI + Bevacizumab   Arm B: Sequential FOLFOXIRI + Bevacizumab   Arm C: FOLFOX + Bevacizumab
STARTED   93   92   95 
COMPLETED   0   0   0 
NOT COMPLETED   93   92   95 
Other                3                6                9 
Lost to Follow-up                2                2                1 
Death                31                36                33 
Sponsor Decision                46                42                42 
Withdrawal of Consent                11                6                10 



  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.
Intent to Treat (ITT) population was defined as all randomized participants regardless of whether they received any dose of study treatment.

Reporting Groups
  Description
Arm A: Concurrent FOLFOXIRI + Bevacizumab Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
Arm B: Sequential FOLFOXIRI + Bevacizumab Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
Arm C: FOLFOX + Bevacizumab Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
Total Total of all reporting groups

Baseline Measures
   Arm A: Concurrent FOLFOXIRI + Bevacizumab   Arm B: Sequential FOLFOXIRI + Bevacizumab   Arm C: FOLFOX + Bevacizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 93   92   95   280 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.0  (11.53)   56.0  (10.46)   57.9  (9.86)   56.7  (10.63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      42  45.2%      40  43.5%      36  37.9%      118  42.1% 
Male      51  54.8%      52  56.5%      59  62.1%      162  57.9% 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Overall Response During First-Line Therapy (ORR1)   [ Time Frame: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years) ]

2.  Primary:   Progression-Free Survival During First-Line Therapy (PFS1)   [ Time Frame: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years) ]

3.  Secondary:   Time to PFS2   [ Time Frame: Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years) ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Randomization until death due to any cause (up to approximately 3 years) ]

5.  Secondary:   Proportion of Participants Who Underwent Liver Metastases Resections   [ Time Frame: Randomization up to approximately 3 years ]

6.  Secondary:   Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases   [ Time Frame: Randomization up to approximately 3 years ]

7.  Secondary:   Percentage of Participants With Adverse Events   [ Time Frame: Randomization up to approximately 3 years ]


  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
This trial was terminated on 12 November 2015, because the primary objective was not met.


  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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01765582     History of Changes
Other Study ID Numbers: ML28442
First Submitted: January 9, 2013
First Posted: January 10, 2013
Results First Submitted: June 2, 2017
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017