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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00360360
First received: August 2, 2006
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Neoplasm, Unknown Primary
Drug: paclitaxel
Drug: carboplatin
Drug: bevacizumab
Drug: erlotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: July 2006
Study Completion Date: March 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360360

Locations
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
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00360360     History of Changes
Other Study ID Numbers: SCRI UNKPRI 19
Study First Received: August 2, 2006
Results First Received: August 15, 2013
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Neoplasm, Unknown Primary

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Bevacizumab
Carboplatin
Paclitaxel
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014