Trial Outcomes & Findings for A Study of Mitomycin C, Irinotecan, and Cetuximab (NCT NCT00271011)

Last Updated: 2015-12-03

Results Overview

The primary objective of this single-arm phase II study is to determine the response rate (Percentage patients with Complete Response (CR) + Percentage of patients with Partial Response (PR)) for the combination of mitomycin C, irinotecan, and cetuximab in metastatic colorectal cancer with wild type K-Ras. Complete response will be defined as the disappearance of all measurable and evaluable disease for at least 4 weeks without the appearance of new lesions. Partial response will be defined as a decrease in the sum of the longest diameter of target lesions by at least 30% for at least 4 weeks without the appearance of any new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

2 months

Results posted on

2015-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Mitomycin C, Irinotecan and Cetuximab Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1\*28 allele will receive irinotecan 110 mg/m2.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Mitomycin C, Irinotecan, and Cetuximab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mitomycin C, Irinotecan and Cetuximab n=13 Participants Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1\*28 allele will receive irinotecan 110 mg/m2.
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months

Population: The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution. Since accrual was not completed the proportion of patients experiencing toxicities could not be statistically determined.

The proportion of patients experiencing hematological and non-hematological toxicities will be summarized.

Outcome measures

Outcome data not reported

Adverse Events

Mitomycin C, Irinotecan and Cetuximab

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mitomycin C, Irinotecan and Cetuximab n=13 participants at risk Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1\*28 allele will receive irinotecan 110 mg/m2.
General disorders Death, Cause Unknown	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Gastrointestinal Obstruction	7.7% 1/13 • Number of events 1

Other adverse events

Other adverse events
Measure	Mitomycin C, Irinotecan and Cetuximab n=13 participants at risk Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1\*28 allele will receive irinotecan 110 mg/m2.
Blood and lymphatic system disorders Hemolysis	23.1% 3/13 • Number of events 3
General disorders Fatigue	69.2% 9/13 • Number of events 13
Psychiatric disorders Insomnia	23.1% 3/13 • Number of events 3
Skin and subcutaneous tissue disorders Photosensitivity	15.4% 2/13 • Number of events 2
Skin and subcutaneous tissue disorders Rash/desquamation	76.9% 10/13 • Number of events 14
Gastrointestinal disorders Anorexia	30.8% 4/13 • Number of events 4
Gastrointestinal disorders Constipation	38.5% 5/13 • Number of events 5
Gastrointestinal disorders Dehydration	15.4% 2/13 • Number of events 2
Gastrointestinal disorders Diarrhea	38.5% 5/13 • Number of events 6
Gastrointestinal disorders Hemorrhoids	15.4% 2/13 • Number of events 2
Gastrointestinal disorders Mucositis/stomatitis	15.4% 2/13 • Number of events 3
Gastrointestinal disorders Nausea	46.2% 6/13 • Number of events 6
Gastrointestinal disorders Vomiting	23.1% 3/13 • Number of events 3
Nervous system disorders Dizziness	15.4% 2/13 • Number of events 2
Nervous system disorders Extrapyramidal/involuntary movement/restlessness	15.4% 2/13 • Number of events 2
Nervous system disorders Neuropathy: sensory	15.4% 2/13 • Number of events 2
Eye disorders Watery eye	15.4% 2/13 • Number of events 2
Gastrointestinal disorders Abdominal Pain	30.8% 4/13 • Number of events 6
Respiratory, thoracic and mediastinal disorders Cough	23.1% 3/13 • Number of events 3
Respiratory, thoracic and mediastinal disorders Dyspnea	38.5% 5/13 • Number of events 5

Additional Information

Dr. Mark Zalupski

University of Michigan Comprehensive Cancer Center

Phone: 734-615-3969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place