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

Brief summary public domain (ClinicalTrials.gov)

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with metastatic pancreatic cancer that did not respond to previous treatment with gemcitabine.

Detailed description public domain (ClinicalTrials.gov)

OBJECTIVES: Primary * Evaluate the 6-month overall survival rate in patients with gemcitabine hydrochloride-refractory metastatic pancreatic cancer treated with bevacizumab and erlotinib hydrochloride. * Determine the safety and toxicity of this regimen in these patients. Secondary * Evaluate the objective response rate in these patients. * Evaluate time to tumor progression in these patients. * Determine the efficacy of this regimen, in terms of the proportion of patients with ≥ 50% decline in carbohydrate antigen 19-9, also called cancer antigen 19-9 (CA19-9) biomarker, in these patients. * Obtain sequential measurements of circulating tumor cells (micrometastases) and endothelial cells in serum and correlate these variables with clinical outcomes (in patients enrolled in UCSF site only). OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at baseline and periodically during study for biomarker/laboratory analysis, including the CA19-9 biomarker. Circulating tumor micrometastases and endothelial cells are also measured in patients enrolled in University of California San Francisco (UCSF) site. After completion of study treatment, patients are followed at 30 days and at 6 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival Rate at 6 Months [6 months]. Number, participants. Bevacizumab Plus Erlotinib (n=36): 8.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Safety and Toxicity [21 weeks]. Number, participants. Rash (Grades 1-3): Bevacizumab Plus Erlotinib (n=36): 26. Diarrhea (Grades 1-3): Bevacizumab Plus Erlotinib (n=36): 9. Hypertension (grade 3): Bevacizumab Plus Erlotinib (n=36): 4. Gastrointestinal Bleeding (Grades 1 & 3): Bevacizumab Plus Erlotinib (n=36): 2. Venous thromboembolic events (Grades 2-3): Bevacizumab Plus Erlotinib (n=36): 3. Pulmonary embolism: Bevacizumab Plus Erlotinib (n=36): 2. Pancratogastic fistula: Bevacizumab Plus Erlotinib (n=36): 1. Suspected hemorrhage into intrapulmonic metastases: Bevacizumab Plus Erlotinib (n=36): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Objective Response as Measured by RECIST Criteria [21 weeks]. Number, participants. Bevacizumab Plus Erlotinib (n=36): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Tumor Progression [from initial therapy to the first objective documentation of tumor progression]. Median, Days (95% Confidence Interval). Bevacizumab Plus Erlotinib (n=36): 40 (35 to 41).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker [21 weeks]. Count Of Participants, Participants. Bevacizumab Plus Erlotinib Hydrochloride (n=26): 4.