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

August 2, 2006
November 11, 2013
July 2006
February 2008   (final data collection date for primary outcome measure)
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 ]
Overall survival
Complete list of historical versions of study NCT00360360 on ClinicalTrials.gov Archive Site
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.
  • Overall toxicity
  • Objective response rate
  • Progression free survival
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasm, Unknown Primary
  • 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
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
Interventions:
  • Drug: paclitaxel
  • Drug: carboplatin
  • Drug: bevacizumab
  • Drug: erlotinib
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. Epub 2009 Dec 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2009
February 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00360360
SCRI UNKPRI 19
No
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
Genentech
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP