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Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

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ClinicalTrials.gov Identifier: NCT00254904
Recruitment Status : Terminated (See Termination Reason in Detailed Description)
First Posted : November 17, 2005
Last Update Posted : March 30, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 15, 2005
First Posted Date  ICMJE November 17, 2005
Last Update Posted Date March 30, 2015
Study Start Date  ICMJE November 2005
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
Overall Survival [ Time Frame: 656 Events ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2005)
Overall Survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2008)
  • Patient Reported Outcomes [ Time Frame: End of treatment ]
  • Overall Safety Profile [ Time Frame: 28 days post PF03512676 dosing ]
  • Progression Free Survival [ Time Frame: Time of primary endpoint ]
  • Time to Tumor Progression [ Time Frame: Time of progressive disease ]
  • Overall Objective Response [ Time Frame: End of treatment ]
  • Duration of Response [ Time Frame: Time of progressive disease ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2005)
Overall confirmed objective response rate, duration of response, progression free survival, time to tumor progression, overall safety profile, patient reported outcomes, pharmacokinetics
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC
Official Title  ICMJE International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of gemcitabine/cisplatin alone.
Detailed Description PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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: Cisplatin
    Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
    Other Name: Platinol-AQ
  • Drug: Gemcitabine
    Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
    Other Name: Gemzar
  • Drug: PF-3512676
    PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
  • Drug: Gemcitabine + Cisplatin
    Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
    Other Name: Gemzar
Study Arms  ICMJE
  • Experimental: A
    Standard of Care chemotherapy plus experimental intervention (PF-3512676)
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Drug: PF-3512676
  • Active Comparator: B
    Standard of Care chemotherapy
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine + Cisplatin
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 Terminated
Actual Enrollment  ICMJE
 (submitted: December 19, 2007)
839
Original Enrollment  ICMJE
 (submitted: November 15, 2005)
800
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
  • No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

  • Small cell or carcinoid lung cancer
  • Known Central Nervous System (CNS) metastasis
  • Pre-existing auto-immune or antibody mediated diseases
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 Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT00254904
Other Study ID Numbers  ICMJE A8501002
Has Data Monitoring Committee Yes
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
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2015

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