Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00365144
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bevacizumab Plus Erlotinib Hydrochloride laboratory biomarker analysis A treatment cycle is 21 days: bevacizumab 15 mg/kg as a 60-90 min infusion once every 21 days, with erlotinib hydrochloride 150 mg by mouth daily Bevacizumab Plus Erlotinib Hydrochloride bevacizumab A treatment cycle is 21 days: bevacizumab 15 mg/kg as a 60-90 min infusion once every 21 days, with erlotinib hydrochloride 150 mg by mouth daily Bevacizumab Plus Erlotinib Hydrochloride erlotinib hydrochloride A treatment cycle is 21 days: bevacizumab 15 mg/kg as a 60-90 min infusion once every 21 days, with erlotinib hydrochloride 150 mg by mouth daily
- Primary Outcome Measures
Name Time Method Overall Survival Rate at 6 Months 6 months Number of participants alive at 6 months
Safety and Toxicity 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)
- Secondary Outcome Measures
Name Time Method Objective Response as Measured by RECIST Criteria 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.
Time to Tumor Progression 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.
Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker 21 weeks
Trial Locations
- Locations (1)
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States