Trial Outcomes & Findings for Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine (NCT NCT00365144)

NCT ID: NCT00365144

Last Updated: 2018-01-19

Results Overview

Number of participants alive at 6 months

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-01-19

Participant Flow

Patients were recruited at a single U.S. clinical site between March 2006 and December 2008

Participant milestones

Measure	Bevacizumab Plus Erlotinib Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine

Baseline characteristics by cohort

Measure	Bevacizumab Plus Erlotinib n=36 Participants Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants
Number of prior lines of systemic therapy 1 Prior Line of Therapy	24 Participants n=5 Participants
Number of prior lines of systemic therapy 2 Prior Lines of Therapy	9 Participants n=5 Participants
Number of prior lines of systemic therapy 3 Prior Lines of Therapy	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants were followed for survival

Number of participants alive at 6 months

Outcome measures

Measure	Bevacizumab Plus Erlotinib n=36 Participants Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
Overall Survival Rate at 6 Months	8 participants

PRIMARY outcome

Timeframe: 21 weeks

Treatment associated toxicities. Adverse event assessments were performed on day 1 of each treatment cycle and at the end of treatment; the longest duration of treatment was 7 cycles (x 3 weeks)

Outcome measures

Measure	Bevacizumab Plus Erlotinib n=36 Participants Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
Safety and Toxicity Rash (Grades 1-3)	26 participants
Safety and Toxicity Diarrhea (Grades 1-3)	9 participants
Safety and Toxicity Hypertension (grade 3)	4 participants
Safety and Toxicity Gastrointestinal Bleeding (Grades 1 & 3)	2 participants
Safety and Toxicity Venous thromboembolic events (Grades 2-3)	3 participants
Safety and Toxicity Pulmonary embolism	2 participants
Safety and Toxicity Pancratogastic fistula	1 participants
Safety and Toxicity Suspected hemorrhage into intrapulmonic metastases	1 participants

SECONDARY outcome

Timeframe: 21 weeks

Participants experiencing objecting 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

Measure	Bevacizumab Plus Erlotinib n=36 Participants Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
Objective Response as Measured by RECIST Criteria	1 participants

SECONDARY outcome

Timeframe: from initial therapy to the first objective documentation of tumor progression

Time to tumor progression (TTP) was defined as the time from initial therapy to the first objective documentation of tumor progression (for patients with measurable disease) or to the data of death, if death was ascribed to progression of disease.

Outcome measures

Measure	Bevacizumab Plus Erlotinib n=36 Participants Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
Time to Tumor Progression	40 Days Interval 35.0 to 41.0

SECONDARY outcome

Timeframe: 21 weeks

Population: Only patients with an elevated baseline CA19-9 (\>2x ULN) were included in this analysis (n = 26).

Outcome measures

Measure	Bevacizumab Plus Erlotinib n=26 Participants Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker	4 Participants

Adverse Events

Bevacizumab Plus Erlotinib

Serious events: 10 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bevacizumab Plus Erlotinib n=36 participants at risk Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
Skin and subcutaneous tissue disorders Rash	2.8% 1/36 • Number of events 1 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Gastrointestinal disorders Diarrhea	2.8% 1/36 • Number of events 1 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Cardiac disorders Hypertension	11.1% 4/36 • Number of events 4 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Vascular disorders Venous Thromboembolic events	8.3% 3/36 • Number of events 3 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Gastrointestinal disorders Gastrointestinal Bleeding	2.8% 1/36 • Number of events 1 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).

Other adverse events

Measure	Bevacizumab Plus Erlotinib n=36 participants at risk Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
Gastrointestinal disorders Upper GI Bleed	2.8% 1/36 • Number of events 1 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Gastrointestinal disorders Abdominal Pain	2.8% 1/36 • Number of events 1 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.8% 1/36 • Number of events 1 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Skin and subcutaneous tissue disorders Rash	69.4% 25/36 • Number of events 25 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Gastrointestinal disorders Diarrhea	22.2% 8/36 • Number of events 8 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Gastrointestinal disorders Gastrointestinal bleeding	2.8% 1/36 • Number of events 1 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Vascular disorders Venous thromboembolic events	5.6% 2/36 • Number of events 2 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Respiratory, thoracic and mediastinal disorders Dyspnea	5.6% 2/36 • Number of events 2 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Gastrointestinal disorders Pancreatogastric fistula	2.8% 1/36 • Number of events 1 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).
Respiratory, thoracic and mediastinal disorders Suspected hemorrhage into intrapulmonic metastases	2.8% 1/36 • Number of events 1 • 21 weeks Participants were followed for adverse events while on study treatment; the longest duration on study was 7 cycles (x 3 weeks). Due to the severe illness of pancreatic cancer patients, the study did not collect AEs and SAEs unrelated to study treatment (due to disease).

Additional Information

Andrew Ko, MD

UCaliforniaSF

Phone: 415-353-9888

Email: andrewko@medicine.ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place