Trial Outcomes & Findings for Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients (NCT NCT00338039)

Results Overview

1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

1 to 4 years

Results posted on

2013-03-22

Participant Flow

Recruitment Period: September 15, 2005 to June 29, 2009. All recruitment done at hospital and medical clinics.

Participant milestones

Participant milestones
Measure	Chemotherapy + Chemoradation Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m\^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Grey delivered in 28 fractions.
Overall Study STARTED	69
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy + Chemoradation n=69 Participants Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
Age Continuous	62 years n=93 Participants
Sex: Female, Male Female	33 Participants n=93 Participants
Sex: Female, Male Male	36 Participants n=93 Participants
Region of Enrollment United States	69 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 to 4 years

1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.

Outcome measures

Outcome measures
Measure	Chemotherapy + Chemoradation n=69 Participants Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
Overall Survival Rate 1-year OS Rate	66.0 percentage of participants
Overall Survival Rate 2-year OS Rate	25.02 percentage of participants
Overall Survival Rate 4-year OS Rate	11.3 percentage of participants

PRIMARY outcome

Timeframe: Baseline to disease progression or death, up to 4 years

Median survival is defined as the time of initiation of the first dose of chemotherapy to the date of death.

Outcome measures

Outcome measures
Measure	Chemotherapy + Chemoradation n=69 Participants Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
Median Overall Survival	19.2 Months Interval 14.2 to 24.2

Adverse Events

Chemotherapy + Chemoradation

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy + Chemoradation n=69 participants at risk Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
Blood and lymphatic system disorders normocytic anemia	1.4% 1/69 • 4 years and 2 months
General disorders dehydration	1.4% 1/69 • 4 years and 2 months
Blood and lymphatic system disorders hyponatremia	1.4% 1/69 • 4 years and 2 months
General disorders allergic reaction during infusion	1.4% 1/69 • 4 years and 2 months
Hepatobiliary disorders biliary sepsis	1.4% 1/69 • 4 years and 2 months
Respiratory, thoracic and mediastinal disorders Sepsis/Respiratory distress	4.3% 3/69 • 4 years and 2 months
Blood and lymphatic system disorders Hyperglycemia	4.3% 3/69 • 4 years and 2 months
General disorders Fever	4.3% 3/69 • 4 years and 2 months

Other adverse events

Other adverse events
Measure	Chemotherapy + Chemoradation n=69 participants at risk Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
Gastrointestinal disorders nausea	10.1% 7/69 • 4 years and 2 months
Gastrointestinal disorders diarrhea	5.8% 4/69 • 4 years and 2 months
Gastrointestinal disorders anorexia	10.1% 7/69 • 4 years and 2 months

Additional Information

Christopher H. Crane, MD / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place