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CPG 7909 Injection in Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00070629
Recruitment Status : Completed
First Posted : October 8, 2003
Last Update Posted : February 10, 2009
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small Cell Lung Drug: CPG 7909 Drug: Chemotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2003
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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.
Other Name: ProMune, PF-3512676

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

Other Name: Paclitaxel (Taxol), docetaxel (TAXOTERE) cisplatin and carboplatin (e.g. PARAPLATIN)
Active Comparator: 2
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


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy- overall response rate (CR & PR) according to the RECIST criteria [ Time Frame: Indeterminate ]
  2. Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations [ Time Frame: Indeterminate ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070629


Locations
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Sponsors and Collaborators
Pfizer
More Information
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00070629    
Other Study ID Numbers: C017
ProMune
CO17
A8501017
First Posted: October 8, 2003    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009
Keywords provided by Pfizer:
Immunotherapy
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Paclitaxel
Docetaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action