Trial Outcomes & Findings for Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer (NCT NCT00810719)

Last Updated: 2018-01-10

Results Overview

Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Up to 36 months

Results posted on

2018-01-10

Participant Flow

Patients were enrolled at University of California Davis and the University of Southern California.

Participant milestones

Participant milestones
Measure	Gemcitabine and Erlotinib The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle. Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26. gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine and Erlotinib n=30 Participants The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle. Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26. gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Gemcitabine and Erlotinib n=30 Participants The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle. Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26. gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Progression Free Survival	2.07 months Interval 1.87 to 5.5

SECONDARY outcome

Timeframe: Up to 36 months

Population: Two patients withdrew consent in the first cycle and were not evaluable for response.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Gemcitabine and Erlotinib n=28 Participants The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle. Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26. gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Response Rate	11 percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Overall survival will be followed for survival every three months until documented progression, death or study termination. If a participant is still alive, survival time is censored at the time of last follow-up.

Outcome measures

Outcome measures
Measure	Gemcitabine and Erlotinib n=30 Participants The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle. Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26. gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Overall Survival	5.67 months Interval 2.83 to 11.87

Adverse Events

Gemcitabine and Erlotinib

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine and Erlotinib n=30 participants at risk The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle. Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26. gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Infections and infestations Lung Infection	3.3% 1/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
General disorders Fatigue	6.7% 2/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Psychiatric disorders Mental Status Changes	3.3% 1/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 2/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Nausea	3.3% 1/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.3% 1/30 • Number of events 1 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Dehydration	3.3% 1/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Diarrhea	3.3% 1/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Skin and subcutaneous tissue disorders Acne	3.3% 1/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Skin and subcutaneous tissue disorders Skin Infection	3.3% 1/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.

Other adverse events

Other adverse events
Measure	Gemcitabine and Erlotinib n=30 participants at risk The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle. Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26. gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Blood and lymphatic system disorders Hemoglobin	56.7% 17/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Blood and lymphatic system disorders Leukopenia	43.3% 13/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Blood and lymphatic system disorders Lymphopenia	43.3% 13/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Blood and lymphatic system disorders Neutropenia	43.3% 13/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Blood and lymphatic system disorders Thrombocytopenia	56.7% 17/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
General disorders Fatigue	26.7% 8/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
General disorders Weight Loss	16.7% 5/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Skin and subcutaneous tissue disorders Dry Skin	16.7% 5/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Skin and subcutaneous tissue disorders Pruritis	6.7% 2/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Skin and subcutaneous tissue disorders Rash	53.3% 16/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Anorexia	23.3% 7/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Dehydration	13.3% 4/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Diarrhea	30.0% 9/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Mucositis	26.7% 8/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Nausea	30.0% 9/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Taste Alteration	13.3% 4/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Gastrointestinal disorders Vomiting	10.0% 3/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 5/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Metabolism and nutrition disorders Alkaline Phosphatase	26.7% 8/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Metabolism and nutrition disorders ALT	26.7% 8/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Metabolism and nutrition disorders AST	26.7% 8/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Metabolism and nutrition disorders Hyperbilirubinemia	30.0% 9/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Metabolism and nutrition disorders Hypokalemia	10.0% 3/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Metabolism and nutrition disorders Hyponatremia	6.7% 2/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Musculoskeletal and connective tissue disorders Muscle Weakness	10.0% 3/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.3% 1/30 • Up to 36 months Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.

Additional Information

Analyst

University of California Davis

Phone: 916 734 0294

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place