Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00366457|
Recruitment Status : Completed
First Posted : August 21, 2006
Results First Posted : March 31, 2017
Last Update Posted : May 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Adenocarcinoma of the Pancreas||Drug: Bevacizumab Drug: Erlotinib Drug: Gemcitabine||Phase 2|
- Participants will receive study treatment as an outpatient. The study treatment will be given in time periods called cycles. Each treatment cycle will be 28 days.
- Gemcitabine will be given intravenously on days 1, 8, and 15 (once per week for the first three weeks) of the treatment cycle.
- Bevacizumab will be given intravenously on days 1 and 15 (once every 2 weeks) of the treatment cycle.
- Erlotinib will be taken orally every day of the treatment cycle.
- Participants will see the doctor or nurse practitioner every week for the first 28 days of treatment. During all of the following cycles, they will see the doctor or nurse practitioner on day 1 and day 15 of each cycle.
- Each 4-week cycle can be repeated until the participant or the doctor decided that they should be removed from the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||July 2011|
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Other Name: rhuMAb VEGFDrug: Erlotinib
Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Other Name: TarcevaDrug: Gemcitabine
Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Other Name: Gemzar
- Time to Tumor Progression [ Time Frame: all patients will be followed for a minimum of 4 months ]
Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death.
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.
- Response Rate [ Time Frame: after at least one 28-day cycle of treatment ]Response rate using RECIST criteria and latest time point available. 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.
- Toxicity Profile [ Time Frame: during and after first 28-day cycle of treatment ]Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening
- Overall Survival [ Time Frame: 5 years ]overall survival (OS) = time from study entry until death from any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366457
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Lawrence S. Blaszkowsky, MD||Massachusetts General Hospital|