Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site
A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site
1 other identifier
interventional
60
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2006
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
October 21, 2013
CompletedDecember 4, 2013
November 1, 2013
1.6 years
August 2, 2006
August 15, 2013
November 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Progression-free Survival
18 months
Study Arms (1)
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
EXPERIMENTALBevacizumab 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
Interventions
Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
Carboplatin AUC 6.0 IV Day 1
Bevacizumab 15mg/kg IV infusion,Day 1
Erlotinib 150 mg by mouth daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
Study Sites (9)
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Related Publications (1)
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.
PMID: 19965914RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D. Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 4, 2006
Study Start
July 1, 2006
Primary Completion
February 1, 2008
Study Completion
March 1, 2009
Last Updated
December 4, 2013
Results First Posted
October 21, 2013
Record last verified: 2013-11