Trial Outcomes & Findings for FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer (NCT NCT02508077)

Last Updated: 2018-08-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

At 4 months

Results posted on

2018-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Panitumumab and FOLFIRI) 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 Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Panitumumab and FOLFIRI) n=1 Participants 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
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: At 4 months

Outcome measures

Outcome measures
Measure	Treatment (Panitumumab and FOLFIRI) n=1 Participants 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
4-month Progression-free Survival (PFS) Rate	0 percentage of participants

Adverse Events

Treatment (Panitumumab and FOLFIRI)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Panitumumab and FOLFIRI) n=1 participants at risk 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
Blood and lymphatic system disorders Leukocytosis	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders blood anion gap decreased.	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypermagnesemia	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Obesity	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hematuria	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	100.0% 1/1 • Number of events 2 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash acneiform	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	100.0% 1/1 • Number of events 1 • Adverse events occurred over a period of 12 weeks. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place