Clinical trialPhase 2Completed
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- August 2006
- Expected end
- July 2011
- Enrollment
- 32 participants
- Sites
- 3
- Primary outcomes
- Time to Tumor Progression
- Sponsor
- Other
- Results posted
- 2017-03-31
- Last update
- 15 May 2017
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Brief summary public domain (ClinicalTrials.gov)
The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
* 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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Time to Tumor Progression [all patients will be followed for a minimum of 4 months]. Median, months (95% Confidence Interval). Gemcitabine, Bevacizumab and Erlotinib (n=30): 3.5 (2.6 to 5.6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Rate [after at least one 28-day cycle of treatment]. Count Of Participants, Participants. Partial Response: Gemcitabine, Bevacizumab and Erlotinib (n=28): 1. Progressive Disease: Gemcitabine, Bevacizumab and Erlotinib (n=28): 8. Stable Disease: Gemcitabine, Bevacizumab and Erlotinib (n=28): 19.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Toxicity Profile [during and after first 28-day cycle of treatment]. Count Of Participants, Participants. Neutrophils: Gemcitabine, Bevacizumab and Erlotinib (n=30): 4. ALT-SGPT: Gemcitabine, Bevacizumab and Erlotinib (n=30): 3. Fatigue: Gemcitabine, Bevacizumab and Erlotinib (n=30): 2. Leukocytes: Gemcitabine, Bevacizumab and Erlotinib (n=30): 2. Rash: acne/acneiform: Gemcitabine, Bevacizumab and Erlotinib (n=30): 2. Thrombosis/thrombus/embolism: Gemcitabine, Bevacizumab and Erlotinib (n=30): 2. Anorexia: Gemcitabine, Bevacizumab and Erlotinib (n=30): 1. AST - SGOT: Gemcitabine, Bevacizumab and Erlotinib (n=30): 1. Hemoglobin: Gemcitabine, Bevacizumab and Erlotinib (n=30): 1. Lymphopenia: Gemcitabine, Bevacizumab and Erlotinib (n=30): 1. Nonneuropathic generalized weakness: Gemcitabine, Bevacizumab and Erlotinib (n=30): 1. Upper GI-hemorrhage NOS: Gemcitabine, Bevacizumab and Erlotinib (n=30): 1. Vascular access-Thrombosis/embolism: Gemcitabine, Bevacizumab and Erlotinib (n=30): 1. Vessel injury - artery - Other NOS: Gemcitabine, Bevacizumab and Erlotinib (n=30): 1. Weight loss: Gemcitabine, Bevacizumab and Erlotinib (n=30): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [5 years]. Median, months (95% Confidence Interval). Gemcitabine, Bevacizumab and Erlotinib (n=30): 6.7 (4.9 to 11.7).