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Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01298570
Recruitment Status : Active, not recruiting
First Posted : February 17, 2011
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Colorectal Cancer Metastatic
Interventions: Drug: Regorafenib (BAY 73-4506)
Drug: FOLFIRI
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
224 participants were consented to the study from 39 institutions from 4/7/11 - 8/10/15.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
30 participants were ineligible, 7 withdrew prior to beginning protocol therapy, 3 could not participate due to study closure, 2 were unable to participate for financial reasons, 1 did not provide a reason for non-participation; 181 patients were enrolled and went on treatment.

Reporting Groups
  Description
Arm A

regorafenib 160 mg + FOLFIRI

Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle

FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.

Arm B

Placebo + FOLFIRI

Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +

FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.


Participant Flow:   Overall Study
    Arm A   Arm B
STARTED   120   61 
COMPLETED [1]   0   0 
NOT COMPLETED   120   61 
Disease progression, relapse during acti                64                40 
Adverse Event                20                2 
Withdrawal by Subject                21                6 
Treatment delay > 4 weeks                4                5 
Physician Decision                4                2 
Other complicating disease                2                1 
Surgery                2                1 
Symptomatic progression/deterioration                3                2 
Death                0                1 
Ineligibility                0                1 
[1] Patients treated until progression



  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.
No text entered.

Reporting Groups
  Description
Arm A

regorafenib 160 mg + FOLFIRI

Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle

FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.

Arm B

Placebo + FOLFIRI

Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +

FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.

Total Total of all reporting groups

Baseline Measures
   Arm A   Arm B   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   61   181 
Age 
[Units: Years]
Median (Full Range)
 62 
 (30 to 94) 
 62 
 (30 to 82) 
 62 
 (30 to 94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      52  43.3%      29  47.5%      81  44.8% 
Male      68  56.7%      32  52.5%      100  55.2% 
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%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      20  16.7%      11  18.0%      31  17.1% 
White      99  82.5%      48  78.7%      147  81.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   0.8%      2   3.3%      3   1.7% 
Region of Enrollment 
[Units: Count of participants]
     
United States   84   43   127 
Ireland   36   18   54 
ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
     
    52  43.3%      23  37.7%      75  41.4% 
    68  56.7%      38  62.3%      106  58.6% 
[1]

A scale by the Eastern Cooperative Oncology Group (ECOG) from 0-5 to describe patient's selfcare ability and activity level.

0, Fully active

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
  3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
  5. Dead
Stage at diagnosis [1] 
[Units: Participants]
Count of Participants
     
    3   2.5%      0   0.0%      3   1.7% 
II      4   3.3%      4   6.6%      8   4.4% 
III      24  20.0%      11  18.0%      35  19.3% 
IV      86  71.7%      46  75.4%      132  72.9% 
Unknown      3   2.5%      0   0.0%      3   1.7% 
[1] Stages I, II, III indicate that cancer is present, and the higher the number the larger the cancer tumor and the more it has spread into nearby tissues. Stage IV indicates that cancer has spread to distant parts of the body.
Prior Biologic Agent 
[Units: Participants]
Count of Participants
     
None      33  27.5%      16  26.2%      49  27.1% 
Bevacizumab      76  63.3%      41  67.2%      117  64.6% 
EGFR inhibitor      11   9.2%      4   6.6%      15   8.3% 
Locally Reported RAS [1] 
[Units: Participants]
Count of Participants
     
Wildtype      49  40.8%      18  29.5%      67  37.0% 
Mutated      54  45.0%      37  60.7%      91  50.3% 
Unknown      17  14.2%      6   9.8%      23  12.7% 
[1] The 3 Ras genes in humans (HRas, KRas, and NRas) are the most common oncogenes in human cancer; some therapies are more effective with nonmutated wildtype genes.
Locally Reported BRAF [1] 
[Units: Participants]
Count of Participants
     
Wildtype      22  18.3%      12  19.7%      34  18.8% 
Mutated      10   8.3%      2   3.3%      12   6.6% 
Unknown      88  73.3%      47  77.0%      135  74.6% 
[1] Many mutations of the BRAF gene are associated with cancer. Some drugs are designed to work with mutated forms of the gene.


  Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 7 years ]

2.  Secondary:   Overall Response(OR)Rate   [ Time Frame: 3 years ]

3.  Secondary:   Disease Control (DC) Rate   [ Time Frame: 3 years ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: 7 years ]

5.  Secondary:   Drug Metabolism   [ Time Frame: 28 days ]

6.  Secondary:   Percentage of Patients With Severe Adverse Events   [ Time Frame: 3 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-1125
e-mail: Robin_V_Johnson@med.unc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01298570     History of Changes
Other Study ID Numbers: LCCC 1029
10-2176 ( Other Identifier: UNC IRB )
First Submitted: February 16, 2011
First Posted: February 17, 2011
Results First Submitted: November 20, 2017
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018