A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site

SCRI Development Innovations, LLC9 sites in 1 country60 target enrollmentJuly 2006

ConditionsNeoplasm, Unknown Primary

Interventionspaclitaxel carboplatin bevacizumab erlotinib

Drugspaclitaxel carboplatin bevacizumab erlotinib

Overview

Phase: Phase 2
Intervention: paclitaxel
Conditions: Neoplasm, Unknown Primary
Sponsor: SCRI Development Innovations, LLC
Enrollment: 60
Locations: 9
Primary Endpoint: Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

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 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 with paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

March 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

SCRI Development Innovations, LLC

Responsible Party

Sponsor

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