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CPG 7909 Injection in Non-Small Cell Lung Cancer

Primary Purpose

Carcinoma, Non-Small Cell Lung

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CPG 7909
Chemotherapy
Chemotherapy
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small Cell Lung focused on measuring Immunotherapy, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Office of Ronald Yanagihara
  • Kenmar Research Institute, LLC
  • Comprehensive Cancer Center of the Dessert
  • Florida Cancer Specialist
  • Indiana Hematology and Oncology Associates
  • Medical Center Vincennes
  • Kentucky Cancer Clinic
  • University of Minnesota
  • Southeast Nebraska Hematology Oncology Consultants, PC
  • VA New Jersey Health Care System
  • HemOnCare
  • Cancer Care of Western North Carolina
  • Providence Portland Medical Center
  • Cancer Care Institute of Carolina
  • Charleston Hematology/Oncology, PA
  • The Family Cancer Center
  • Marshfield Clinic
  • Queen Elizabeth II Health
  • Ottawa Regional Cancer Center
  • McGill University
  • Staedtisches Krankenhaus Martha-Maria
  • Universitätsklinikum Mannheim der Universität Heidelberg
  • St. Vincentius-Kliniken gAG, Hamatologie-Onkologie
  • Klinikum Rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection

Chemotherapy (a taxane and a platinum compound)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 6, 2003
Last Updated
February 9, 2009
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00070629
Brief Title
CPG 7909 Injection in Non-Small Cell Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small Cell Lung
Keywords
Immunotherapy, lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
Arm Title
2
Arm Type
Active Comparator
Arm Description
Chemotherapy (a taxane and a platinum compound)
Intervention Type
Drug
Intervention Name(s)
CPG 7909
Other Intervention Name(s)
ProMune, PF-3512676
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Paclitaxel (Taxol), docetaxel (TAXOTERE) cisplatin and carboplatin (e.g. PARAPLATIN)
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy- overall response rate (CR & PR) according to the RECIST criteria
Time Frame
Indeterminate
Title
Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations
Time Frame
Indeterminate
Secondary Outcome Measure Information:
Title
Secondary Efficacy
Time Frame
Indeterminate
Title
compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups
Time Frame
Indeterminate
Title
duration of overall response (CR, PR), survival time, and time to disease progression.
Time Frame
Indeterminate
Title
To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination.
Time Frame
Indeterminate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Office of Ronald Yanagihara
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
Facility Name
Kenmar Research Institute, LLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Comprehensive Cancer Center of the Dessert
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Florida Cancer Specialist
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Indiana Hematology and Oncology Associates
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Medical Center Vincennes
City
Vincennes
State/Province
Indiana
ZIP/Postal Code
47591
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Southeast Nebraska Hematology Oncology Consultants, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
VA New Jersey Health Care System
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
HemOnCare
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
Cancer Care of Western North Carolina
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Cancer Care Institute of Carolina
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29801
Country
United States
Facility Name
Charleston Hematology/Oncology, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
The Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Queen Elizabeth II Health
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Ottawa Regional Cancer Center
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Staedtisches Krankenhaus Martha-Maria
City
Halle-Dolau
ZIP/Postal Code
D-06120
Country
Germany
Facility Name
Universitätsklinikum Mannheim der Universität Heidelberg
City
Heidelberg
Country
Germany
Facility Name
St. Vincentius-Kliniken gAG, Hamatologie-Onkologie
City
Karlsruhe
ZIP/Postal Code
D76137
Country
Germany
Facility Name
Klinikum Rechts der Isar
City
Munchen
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

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CPG 7909 Injection in Non-Small Cell Lung Cancer

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