Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site
Completed · Phase 2
Conditions studied: Neoplasm, Unknown Primary
In brief
We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion.
Key facts
- Study ID
- NCT00360360
- Run by
- SCRI Development Innovations, LLC
- People needed
- 60
- Starts
- 2006-07-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2013-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Integrated Community Oncology Network — Jacksonville, Florida, United States
- Northeast Georgia Medical Center — Gainesville, Georgia, United States
- Oncology Hematology Associates of SW Indiana — Evansville, Indiana, United States
- Graves-Gilbert Clinic — Bowling Green, Kentucky, United States
- Baton Rouge General Medical Center — Baton Rouge, Louisiana, United States
- Oncology Hematology Care — Cincinnati, Ohio, United States
- Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
- Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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