Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00070629
Previous Study | Return to List | Next Study

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

Tracking Information
First Submitted Date  ICMJE October 6, 2003
First Posted Date  ICMJE October 8, 2003
Last Update Posted Date February 10, 2009
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
  • Efficacy- overall response rate (CR & PR) according to the RECIST criteria [ Time Frame: Indeterminate ]
  • Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations [ Time Frame: Indeterminate ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
  • Secondary Efficacy [ Time Frame: Indeterminate ]
  • compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups [ Time Frame: Indeterminate ]
  • duration of overall response (CR, PR), survival time, and time to disease progression. [ Time Frame: Indeterminate ]
  • To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination. [ Time Frame: Indeterminate ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CPG 7909 Injection in Non-Small Cell Lung Cancer
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small Cell Lung
Intervention  ICMJE
  • 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

  • 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)
Study Arms  ICMJE
  • Experimental: 1
    Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
    Interventions:
    • Drug: CPG 7909
    • Drug: Chemotherapy
  • Active Comparator: 2
    Chemotherapy (a taxane and a platinum compound)
    Intervention: Drug: Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2009)
116
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
112
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00070629
Other Study ID Numbers  ICMJE C017
ProMune
CO17
A8501017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pfizer
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP