Status:
COMPLETED
Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Neoplasm, Unknown Primary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment o...
Detailed Description
All eligible patients will receive: * Bevacizumab 15mg/kg IV infusion,Day 1 * Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 * Carboplatin AUC 6.0 IV Day 1 * Erlotinib 150 mg by mouth daily The reg...
Eligibility Criteria
Inclusion
- Biopsy proven metastatic carcinoma with the following light microscopic histologies: adenocarcinoma, poorly differentiated carcinoma(must have immunoperoxidase stains to rule out lymphoma, neuroendocrine carcinoma),or poorly differentiated squamous carcinoma.
- ECOG performance status 0-1
- No previous treatment with any systemic therapy
- Adequate kidney, liver and bone marrow function
- Be able to understand the nature of the study and give written informed consent
Exclusion
- The following specific syndromes:
- Neuroendocrine carcinoma
- Women with adenocarcinoma isolated to axillary lymph nodes
- Women with adenocarcinoma isolated to peritoneal involvement
- Carcinoma involving only one site with resectable tumors at that site
- Squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes
- Uncontrolled brain metastases and all patients with meningeal involvement
- Women pregnant or lactating
- Clinically significant cardiovascular disease
- History of myocardial infarction or stroke within 6 months
- Clinical history of hemoptysis or hematemesis
- Patients with PEG tubes or G-tubes
- Proteinuria
- History of bleeding diathesis 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. You can then decide if you wish to participate.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00360360
Start Date
July 1 2006
End Date
March 1 2009
Last Update
December 4 2013
Active Locations (9)
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1
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
2
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
3
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
4
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States, 42101