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

NCT ID: NCT00360360

Last Updated: 2013-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Neoplasm, Unknown Primary

Keywords

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Neoplasm, Unknown Primary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab/Paclitaxel/Carboplatin/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

Group Type EXPERIMENTAL

paclitaxel

Intervention Type DRUG

Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1

carboplatin

Intervention Type DRUG

Carboplatin AUC 6.0 IV Day 1

bevacizumab

Intervention Type DRUG

Bevacizumab 15mg/kg IV infusion,Day 1

erlotinib

Intervention Type DRUG

Erlotinib 150 mg by mouth daily

Interventions

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paclitaxel

Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1

Intervention Type DRUG

carboplatin

Carboplatin AUC 6.0 IV Day 1

Intervention Type DRUG

bevacizumab

Bevacizumab 15mg/kg IV infusion,Day 1

Intervention Type DRUG

erlotinib

Erlotinib 150 mg by mouth daily

Intervention Type DRUG

Other Intervention Names

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Taxol Paraplatin Avastin Tarceva

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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Integrated Community Oncology Network

Jacksonville, Florida, United States

Site Status

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, United States

Site Status

Graves-Gilbert Clinic

Bowling Green, Kentucky, United States

Site Status

Baton Rouge General Medical Center

Baton Rouge, Louisiana, United States

Site Status

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Site Status

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Hainsworth JD, Spigel DR, Thompson DS, Murphy PB, Lane CM, Waterhouse DM, Naot Y, Greco FA. Paclitaxel/carboplatin plus bevacizumab/erlotinib in the first-line treatment of patients with carcinoma of unknown primary site. Oncologist. 2009 Dec;14(12):1189-97. doi: 10.1634/theoncologist.2009-0112. Epub 2009 Dec 4.

Reference Type RESULT
PMID: 19965914 (View on PubMed)

Other Identifiers

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SCRI UNKPRI 19

Identifier Type: -

Identifier Source: org_study_id