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

Neoplasm, Unknown Primary Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360360
• Other study ID #: SCRI UNKPRI 19
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2006
• Last updated: November 11, 2013
• Start date: July 2006
• Est. completion date: March 2009

Study information

• Verified date: November 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Neoplasm, Unknown Primary
• Neoplasms, Unknown Primary

Intervention

Drug:
• paclitaxel
Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
• carboplatin
Carboplatin AUC 6.0 IV Day 1
• bevacizumab
Bevacizumab 15mg/kg IV infusion,Day 1
• erlotinib
Erlotinib 150 mg by mouth daily

Locations

Country	Name	City	State
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	Graves-Gilbert Clinic	Bowling Green	Kentucky
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
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	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death		18 months	No
Secondary	Progression-free Survival	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.	18 months	No

External Links

•   Published article in The Oncologist