CPG 7909 Injection in Non-Small Cell Lung Cancer

Carcinoma, Non-Small Cell Lung Clinical Trial

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

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
• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

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