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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00070629
Other study ID # C017
Secondary ID ProMuneCO17A8501
Status Completed
Phase Phase 2
First received October 6, 2003
Last updated February 9, 2009
Start date May 2003
Est. completion date July 2007

Study information

Verified date February 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
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
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

Locations

Country Name City State
Canada Queen Elizabeth II Health Halifax Nova Scotia
Canada McGill University Montreal Quebec
Canada Ottawa Regional Cancer Center Ottawa Ontario
Germany Staedtisches Krankenhaus Martha-Maria Halle-Dolau
Germany Universitätsklinikum Mannheim der Universität Heidelberg Heidelberg
Germany St. Vincentius-Kliniken gAG, Hamatologie-Onkologie Karlsruhe
Germany Klinikum Rechts der Isar Munchen
United States Cancer Care Institute of Carolina Aiken South Carolina
United States Cancer Care of Western North Carolina Asheville North Carolina
United States HemOnCare Brooklyn New York
United States Charleston Hematology/Oncology, PA Charleston South Carolina
United States The Family Cancer Center Collierville Tennessee
United States VA New Jersey Health Care System East Orange New Jersey
United States Florida Cancer Specialist Fort Myers Florida
United States Office of Ronald Yanagihara Gilroy California
United States Kentucky Cancer Clinic Hazard Kentucky
United States Indiana Hematology and Oncology Associates Indianapolis Indiana
United States Southeast Nebraska Hematology Oncology Consultants, PC Lincoln Nebraska
United States Kenmar Research Institute, LLC Los Angeles California
United States Marshfield Clinic Marshfield Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Comprehensive Cancer Center of the Dessert Palm Springs California
United States Providence Portland Medical Center Portland Oregon
United States Medical Center Vincennes Vincennes Indiana

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy- overall response rate (CR & PR) according to the RECIST criteria Indeterminate No
Primary Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations Indeterminate Yes
Secondary Secondary Efficacy Indeterminate No
Secondary compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups Indeterminate No
Secondary duration of overall response (CR, PR), survival time, and time to disease progression. Indeterminate No
Secondary To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination. Indeterminate No
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