Trial Outcomes & Findings for Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC) (NCT NCT00642746)

Last Updated: 2014-09-26

Results Overview

The primary outcome measure will be the response rates of radiographically measurable disease. Response rate of disease will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Disease response assessed after every 2 Treatment Cycles, or around 8 weeks.

Results posted on

2014-09-26

Participant Flow

Enrollment was done from 3/28/2008 to the study closure of 12/19/2011. Patients were recruited from the Oregon Health and Science University medical clinic as well as via referral from associated regional medical clinics.

Patients were stratified according to whether they had received 5-Fluorouracil/Leucovorin with Oxaliplatin or Fluorouracil, Leucovorin, and Irinotecan for their 1st line treatment. Whichever they had not received in the 1st line setting, they received on trial. 16 patients signed consent. 2 patients withdrew, 3 ineligible, and 1 unevaluable.

Participant milestones

Participant milestones
Measure	FOLFIRI With Erlotinib	FOLFOX With Erlotinib
Overall Study STARTED	10	1
Overall Study COMPLETED	9	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	FOLFIRI With Erlotinib	FOLFOX With Erlotinib
Overall Study Patient unevaluable	1	0

Baseline Characteristics

Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFIRI With Erlotinib n=10 Participants	FOLFOX With Erlotinib n=1 Participants	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 participants n=5 Participants	1 participants n=7 Participants	7 participants n=5 Participants
Age, Categorical >=65 years	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	1 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease response assessed after every 2 Treatment Cycles, or around 8 weeks.

Population: Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator.

Outcome measures

Outcome measures
Measure	FOLFIRI With Erlotinib n=10 Participants	FOLFOX With Erlotinib n=1 Participants
Response Rates of Radiographically Measurable Disease Best Outcome - Complete Response	0 Number of Patients	0 Number of Patients
Response Rates of Radiographically Measurable Disease Best Outcome - Partial Response	1 Number of Patients	0 Number of Patients
Response Rates of Radiographically Measurable Disease Best Outcome- Stable Disease	5 Number of Patients	1 Number of Patients
Response Rates of Radiographically Measurable Disease Best Outcome - Progressive Disease	4 Number of Patients	0 Number of Patients

SECONDARY outcome

Timeframe: Upon completion of follow-up, for an average of 99 days following the initiation of study treatment.

Population: Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator. 95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient.

Time to disease progression from start of second-line experimental regimen. Disease progression will be measured per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.

Outcome measures

Outcome measures
Measure	FOLFIRI With Erlotinib n=10 Participants	FOLFOX With Erlotinib n=1 Participants
Second-line Progression Free Survival	83 Days Interval 15.0 to 127.0	125 Days

SECONDARY outcome

Timeframe: Documented by Follow-up CT scans following first line treatment, average of 225 days.

Population: 95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient.

Number of days from the initiation of first line treatment to first documented progression. Progression will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progression free survival (time to progression or death, whichever occurs first) is the same as time to progression as all of the patients in this trial progressed.

Outcome measures

Outcome measures
Measure	FOLFIRI With Erlotinib n=10 Participants	FOLFOX With Erlotinib n=1 Participants
Time to Second Progression (From Start of First-Line Regimen)	83 Days Interval 15.0 to 127.0	125 Days

Adverse Events

FOLFIRI With Erlotinib

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

FOLFOX With Erlotinib

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FOLFIRI With Erlotinib n=9 participants at risk	FOLFOX With Erlotinib n=1 participants at risk
Gastrointestinal disorders GI Hemorrhage	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Ascites	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
General disorders Weakness	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
General disorders Fatigue	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Blood and lymphatic system disorders Leukopenia	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Investigations Hyperbilirubinemia	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Blood and lymphatic system disorders Thrombocytopenia	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.

Other adverse events

Other adverse events
Measure	FOLFIRI With Erlotinib n=9 participants at risk	FOLFOX With Erlotinib n=1 participants at risk
Blood and lymphatic system disorders Neutropenia	66.7% 6/9 • Number of events 6 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	100.0% 1/1 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
General disorders Oral Pain	22.2% 2/9 • Number of events 2 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Skin and subcutaneous tissue disorders Rash	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Metabolism and nutrition disorders Hyponatremia	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Blood and lymphatic system disorders International Normalized Ratio Elevation	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
General disorders Abdominal Pain	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Gastrointestinal disorders GI Bleed	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
General disorders Fatigue	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.
Blood and lymphatic system disorders Leukopenia	11.1% 1/9 • Number of events 1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.	0.00% 0/1 • Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 years.

Additional Information

Charles Lopez, MD

OHSU Knight Cancer Institute

Phone: 503-494-8534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place