Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site

Launched by SCRI DEVELOPMENT INNOVATIONS, LLC · Aug 2, 2006

Keywords

ClinConnect Summary

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 regimen will be repeated every 21 days for a total of 4 courses. Patients will be initially evaluated for response after completing 2 courses (6 weeks) of treatment. Patients with an objective tumor response or stable disease will continue treatment for another 2 courses. Patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• * 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.