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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00360360
Recruitment Status : Completed
First Posted : August 4, 2006
Results First Posted : October 21, 2013
Last Update Posted : December 4, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasm, Unknown Primary Drug: paclitaxel Drug: carboplatin Drug: bevacizumab Drug: erlotinib Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site
Study Start Date : July 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: paclitaxel
Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
Other Name: Taxol

Drug: carboplatin
Carboplatin AUC 6.0 IV Day 1
Other Name: Paraplatin

Drug: bevacizumab
Bevacizumab 15mg/kg IV infusion,Day 1
Other Name: Avastin

Drug: erlotinib
Erlotinib 150 mg by mouth daily
Other Name: Tarceva


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360360


Locations
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United States, Florida
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Indiana
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
United States, Kentucky
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Investigators
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Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
More Information
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Additional Information:

Publications of Results:

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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00360360    
Other Study ID Numbers: SCRI UNKPRI 19
First Posted: August 4, 2006    Key Record Dates
Results First Posted: October 21, 2013
Last Update Posted: December 4, 2013
Last Verified: November 2013
Keywords provided by SCRI Development Innovations, LLC:
Neoplasm, Unknown Primary
Additional relevant MeSH terms:
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Neoplasms, Unknown Primary
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Paclitaxel
Bevacizumab
Carboplatin
Erlotinib Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors