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

Phase 2

Completed

• Conditions: Neoplasm, Unknown Primary
• Interventions: Drug: paclitaxel; Drug: carboplatin; Drug: bevacizumab; Drug: erlotinib

• Registration Number: NCT00360360
• Lead Sponsor: SCRI Development Innovations, LLC

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-02
• Study First Submitted QC: 2006-08-02
• Study First Posted: 2006-08-04
• Primary Completion: 2008-02
• Study Completion: 2009-03
• Results First Submitted: 2013-08-15
• Results First Submitted QC: 2013-08-15
• Results First Posted: 2013-10-21
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib	carboplatin	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
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib	paclitaxel	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
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib	bevacizumab	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
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib	erlotinib	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

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	18 months

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	18 months	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Trial Locations

Locations (9)

Spartanburg Regional Medical Center; 🇺🇸 Spartanburg, South Carolina, United States

Graves-Gilbert Clinic; 🇺🇸 Bowling Green, Kentucky, United States

Oncology Hematology Associates of SW Indiana; 🇺🇸 Evansville, Indiana, United States

Northeast Georgia Medical Center; 🇺🇸 Gainesville, Georgia, United States

Integrated Community Oncology Network; 🇺🇸 Jacksonville, Florida, United States

Baton Rouge General Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States

Chattanooga Oncology Hematology Associates; 🇺🇸 Chattanooga, Tennessee, United States

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States