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FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02508077
Recruitment Status : Terminated (Poor Accrual)
First Posted : July 24, 2015
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Colorectal Carcinoma
Stage IVA Colorectal Cancer
Stage IVB Colorectal Cancer
Interventions Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Biological: Panitumumab
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Panitumumab and FOLFIRI)
Hide Arm/Group Description

Patients receive 6mg/kg panitumumab IV over 30-90 minutes, 180mg/m2 irinotecan hydrochloride IV over 90 minutes, 400mg/m2 leucovorin calcium PO, and 2400mg/m2 fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Fluorouracil: Given IV

Irinotecan Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given PO

Panitumumab: Given IV

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Treatment (Panitumumab and FOLFIRI)
Hide Arm/Group Description

Patients receive 6mg/kg panitumumab IV over 30-90 minutes, 180mg/m2 irinotecan hydrochloride IV over 90 minutes, 400mg/m2 leucovorin calcium PO, and 2400mg/m2 fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Fluorouracil: Given IV

Irinotecan Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given PO

Panitumumab: Given IV

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
57
(57 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title 4-month Progression-free Survival (PFS) Rate
Hide Description PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Will be estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including baseline sum), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame At 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Panitumumab and FOLFIRI)
Hide Arm/Group Description:

Patients receive 6mg/kg panitumumab IV over 30-90 minutes, 180mg/m2 irinotecan hydrochloride IV over 90 minutes, 400mg/m2 leucovorin calcium PO, and 2400mg/m2 fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Fluorouracil: Given IV

Irinotecan Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given PO

Panitumumab: Given IV

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame Adverse events occurred over a period of 12 weeks.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Treatment (Panitumumab and FOLFIRI)
Hide Arm/Group Description

Patients receive 6mg/kg panitumumab IV over 30-90 minutes, 180mg/m2 irinotecan hydrochloride IV over 90 minutes, 400mg/m2 leucovorin calcium PO, and 2400mg/m2 fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Fluorouracil: Given IV

Irinotecan Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given PO

Panitumumab: Given IV

All-Cause Mortality
Treatment (Panitumumab and FOLFIRI)
Affected / at Risk (%)
Total   0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Panitumumab and FOLFIRI)
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Panitumumab and FOLFIRI)
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Leukocytosis *  1/1 (100.00%)  1
blood anion gap decreased. *  1/1 (100.00%)  1
Gastrointestinal disorders   
Nausea *  1/1 (100.00%)  1
Metabolism and nutrition disorders   
Hypermagnesemia *  1/1 (100.00%)  1
Hyponatremia *  1/1 (100.00%)  1
Obesity *  1/1 (100.00%)  1
Renal and urinary disorders   
Hematuria *  1/1 (100.00%)  1
Skin and subcutaneous tissue disorders   
Dry skin *  1/1 (100.00%)  2
Rash acneiform *  1/1 (100.00%)  1
Rash maculo-papular *  1/1 (100.00%)  1
Vascular disorders   
Thromboembolic event *  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
Study was terminated early due to poor accrual.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
Phone: 626-218-5265
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02508077     History of Changes
Other Study ID Numbers: 15117
NCI-2015-01241 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
118713
15117 ( Other Identifier: City of Hope Comprehensive Cancer Center )
First Submitted: July 22, 2015
First Posted: July 24, 2015
Results First Submitted: July 20, 2018
Results First Posted: August 16, 2018
Last Update Posted: August 16, 2018