Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine
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.
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Metastatic Gemcitabine-Refractory Pancreatic Cancer|
- Overall Survival Rate at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of participants alive at 6 months
- Safety and Toxicity [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]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)
- Objective Response as Measured by RECIST Criteria [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]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.
- Time to Tumor Progression [ Time Frame: 132 days ] [ Designated as safety issue: No ]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. Patients initially without measurable disease were included in the analysis based either on the appearance of new measurable lesions or on strongly suggestive radiographic evidence of progression of non-measurable disease). Participants were followed for tumor progression; the longest duration without progression was 132 days.
- Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: Bevacizumab Plus Erlotinib||Biological: bevacizumab Drug: erlotinib hydrochloride Other: laboratory biomarker analysis|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365144
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Andrew Ko, MD||University of California, San Francisco|