Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

Study Overview
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Brief Summary
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This trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This trial will be one of the first clinical trials to evaluate a combination of targeted agents in the treatment of a solid tumor.

Detailed Description
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Upon determination of eligibility, patients will be receive: Bevacizumab + Erlotinib

Official Title
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A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

Conditions
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Neoplasms, Unknown Primary

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in this study, you must meet the following criteria: Carcinoma of unknown primary site confirmed by biopsy Measurable disease ECOG performance status must be 0-1 Adequate bone marrow, liver and kidney Understand the nature of this study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age< 18 years May not have received EGFR inhibitors History of acute myocardial infarction within 6 months Clinically significant cardiovascular disease Moderate to severe peripheral vascular disease. History of stroke within 6 months History of abdominal fistula, perforation, or abscess within 6 months Active concurrent infections Serious underlying medical conditions Active brain metastases Women who are pregnant or lactating. PEG or G-tube Proteinuria Any nonhealing wound, ulcer, or bone fracture. Any clinical evidence or history of bleeding, clotting or coagulopathy Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bevacizumab|nan|
|Drug: Erlotinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Overall survival |  |  | 
| Overall tolerability |  |  | 
| Overall toxicity |  |  |