CPG 7909 Injection in Non-Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Carcinoma, Non-Small Cell Lung
• Interventions: Drug: CPG 7909; Drug: Chemotherapy

• Registration Number: NCT00070629
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2003-10-06
• Study First Submitted QC: 2003-10-07
• Study First Posted: 2003-10-08
• Study Completion: 2007-07
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-09
• Last Update Posted: 2009-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CPG 7909	Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
1	Chemotherapy	Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
2	Chemotherapy	Chemotherapy (a taxane and a platinum compound)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (24)

Office of Ronald Yanagihara; 🇺🇸 Gilroy, California, United States

Kenmar Research Institute, LLC; 🇺🇸 Los Angeles, California, United States

Comprehensive Cancer Center of the Dessert; 🇺🇸 Palm Springs, California, United States

Florida Cancer Specialist; 🇺🇸 Fort Myers, Florida, United States

Indiana Hematology and Oncology Associates; 🇺🇸 Indianapolis, Indiana, United States

Medical Center Vincennes; 🇺🇸 Vincennes, Indiana, United States

Kentucky Cancer Clinic; 🇺🇸 Hazard, Kentucky, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Southeast Nebraska Hematology Oncology Consultants, PC; 🇺🇸 Lincoln, Nebraska, United States

VA New Jersey Health Care System; 🇺🇸 East Orange, New Jersey, United States

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