CPG 7909 Injection in Non-Small Cell Lung Cancer

February 9, 2009 updated by: Pfizer

Promune™ (CPG 7909 Injection) In Combination With Chemotherapy In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer, A Randomized, Multi-Center, Controlled, Phase 2 Study

Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
  • Germany
      • Halle-Dolau, Germany, D-06120
        • Staedtisches Krankenhaus Martha-Maria
      • Heidelberg, Germany
        • Universitätsklinikum Mannheim der Universität Heidelberg
      • Karlsruhe, Germany, D76137
        • St. Vincentius-Kliniken gAG, Hamatologie-Onkologie
      • Munchen, Germany, 81675
        • Klinikum rechts der Isar
  • United States
    • California
      • Gilroy, California, United States, 95020
        • Office of Ronald Yanagihara
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute, LLC
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Center of the Dessert
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialist
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Hematology and Oncology Associates
      • Vincennes, Indiana, United States, 47591
        • Medical Center Vincennes
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Clinic
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Southeast Nebraska Hematology Oncology Consultants, PC
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • VA New Jersey Health Care System
    • New York
      • Brooklyn, New York, United States, 11212
        • HemOnCare
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Cancer Care of Western North Carolina
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • South Carolina
      • Aiken, South Carolina, United States, 29801
        • Cancer Care Institute of Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology/Oncology, PA
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • The Family Cancer Center
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC).
  • Patients must have measurable disease according to the RECIST criteria.

Exclusion Criteria:

  • Prior treatment with chemotherapy; patients may have received prior radiotherapy.
  • Patients with suspected or known CNS metastases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
Drug: CPG 7909
CPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle.
Other Names:
  • ProMune, PF-3512676
Drug: Chemotherapy

A taxane and a platinum compound given on week one of three-week cycles:

Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6

Other Names:
  • Paclitaxel (Taxol), docetaxel (TAXOTERE) cisplatin and carboplatin (e.g. PARAPLATIN)
Active Comparator: 2
Chemotherapy (a taxane and a platinum compound)
Drug: Chemotherapy

A taxane and a platinum compound given on week one of three-week cycles:

Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6

Other Names:
  • Paclitaxel (Taxol), docetaxel (TAXOTERE) cisplatin and carboplatin (e.g. PARAPLATIN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy- overall response rate (CR & PR) according to the RECIST criteria
Time Frame: Indeterminate
Indeterminate
Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations
Time Frame: Indeterminate
Indeterminate

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary Efficacy
Time Frame: Indeterminate
Indeterminate
compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups
Time Frame: Indeterminate
Indeterminate
duration of overall response (CR, PR), survival time, and time to disease progression.
Time Frame: Indeterminate
Indeterminate
To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination.
Time Frame: Indeterminate
Indeterminate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

October 6, 2003

First Submitted That Met QC Criteria

October 7, 2003

First Posted (Estimate)

October 8, 2003

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C017
  • CO17
  • ProMune
  • A8501017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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