CPG 7909 Injection in Non-Small Cell Lung Cancer

NCT00070629 | Completed Phase 2

• 4 other identifiers: C017ProMuneCO17A8501017
• Study Type: interventional
• Target: 116
• Locations: 3 countries
• Sites: 24

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.

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

Immunotherapy; lung cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: CPG 7909; Drug: Chemotherapy

2

ACTIVE COMPARATOR

Chemotherapy (a taxane and a platinum compound)

Drug: Chemotherapy

Interventions

CPG 7909 DRUG

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.

Also known as: ProMune, PF-3512676

1

Chemotherapy DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

Office of Ronald Yanagihara

Gilroy, California, 95020, United States

Location

Kenmar Research Institute, LLC

Los Angeles, California, 90057, United States

Location

Comprehensive Cancer Center of the Dessert

Palm Springs, California, 92262, United States

Location

Florida Cancer Specialist

Fort Myers, Florida, 33901, United States

Location

Indiana Hematology and Oncology Associates

Indianapolis, Indiana, 46202, United States

Location

Medical Center Vincennes

Vincennes, Indiana, 47591, United States

Location

Kentucky Cancer Clinic

Hazard, Kentucky, 41701, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Southeast Nebraska Hematology Oncology Consultants, PC

Lincoln, Nebraska, 68516, United States

Location

VA New Jersey Health Care System

East Orange, New Jersey, 07018, United States

Location

HemOnCare

Brooklyn, New York, 11212, United States

Location

Cancer Care of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Cancer Care Institute of Carolina

Aiken, South Carolina, 29801, United States

Location

Charleston Hematology/Oncology, PA

Charleston, South Carolina, 29403, United States

Location

The Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Queen Elizabeth II Health

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Ottawa Regional Cancer Center

Ottawa, Ontario, K1H 1C4, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Staedtisches Krankenhaus Martha-Maria

Halle-Dolau, D-06120, Germany

Location

Universitätsklinikum Mannheim der Universität Heidelberg

Heidelberg, Germany

Location

St. Vincentius-Kliniken gAG, Hamatologie-Onkologie

Karlsruhe, D76137, Germany

Location

Klinikum Rechts der Isar

München, 81675, Germany

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

ProMune; Drug Therapy; Paclitaxel; Docetaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2003
• First Posted: October 8, 2003
• Study Start: May 1, 2003
• Study Completion: July 1, 2007
• Last Updated: February 10, 2009

Record last verified: 2009-02

Locations

US (17); CA (3); DE (4)