CPG 7909 Injection in Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00070629

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non-Small Cell Lung	Drug: CPG 7909 Drug: Chemotherapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Paclitaxel Carboplatin Docetaxel

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Efficacy- overall response rate (CR & PR) according to the RECIST criteria [ Time Frame: Indeterminate ] [ Designated as safety issue: No ]
Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations [ Time Frame: Indeterminate ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary Efficacy [ Time Frame: Indeterminate ] [ Designated as safety issue: No ]
compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups [ Time Frame: Indeterminate ] [ Designated as safety issue: No ]
duration of overall response (CR, PR), survival time, and time to disease progression. [ Time Frame: Indeterminate ] [ Designated as safety issue: No ]
To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination. [ Time Frame: Indeterminate ] [ Designated as safety issue: No ]

Enrollment:	116
Study Start Date:	May 2003
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection	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. Drug: 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
2: Active Comparator Chemotherapy (a taxane and a platinum compound)	Drug: 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

Arms

Assigned Interventions

1: Experimental

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

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.

Drug: 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

2: Active Comparator

Chemotherapy (a taxane and a platinum compound)

Drug: 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070629

Show 24 Study Locations

Sponsors and Collaborators

Pfizer

More Information

Additional Information:

Coley Pharmaceutical Group This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	C017, ProMune, CO17, A8501017
Study First Received:	October 6, 2003
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00070629 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Immunotherapy
lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Docetaxel
Neoplasms by Site
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators

Carboplatin
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases
Tubulin Modulators
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009