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Trial of Pemetrexed With or Without PF-3512676 in Advanced 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: NCT00321308
Recruitment Status : Terminated (See Termination Reason in Detailed Description.)
First Posted : May 3, 2006
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 2, 2006
First Posted Date  ICMJE May 3, 2006
Last Update Posted Date September 28, 2009
Study Start Date  ICMJE September 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Progression-free survival [ Time Frame: 110 Events ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2006)
Progression-free survival
Change History Complete list of historical versions of study NCT00321308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Overall Survival [ Time Frame: Time of death ]
  • Overall Safety Profile [ Time Frame: 28 days post treatment ]
  • Patient Reported Outcome [ Time Frame: End of Treatment ]
  • Time to Tumor Progression [ Time Frame: End of treatment ]
  • Overall Objective Response Rate [ Time Frame: Time of disease progressive disease ]
  • Duration of Response [ Time Frame: Time of disease progression ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2006)
Time to Tumor Progression Overall Objective Response Rate Duration of Response Overall Survival Overall Safety Profile Patient Reported Outcome Pharmacokinetic Parameters
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease
Brief Summary To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen
Detailed Description PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.
Study Type  ICMJE Interventional
Study Phase 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: pemetrexed
    500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
    Other Name: Alimta
  • Drug: pemetrexed + PF-3512676
    pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
    Other Name: Alimta
Study Arms
  • Active Comparator: B
    Standard of care chemotherapy
    Intervention: Drug: pemetrexed
  • Experimental: A
    Standard of care chemotherapy plus experimental intervention (PF-3512676)
    Intervention: Drug: pemetrexed + PF-3512676
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 11, 2008)
36
Original Enrollment  ICMJE
 (submitted: May 2, 2006)
130
Actual Study Completion Date January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Locally advanced or metastatic NSCLC
  • Measurable disease
  • ECOG PS 0 or 1

Exclusion Criteria:

  • Known CNS metastasis
  • Pre-existing autoimmune or antibody mediated disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00321308
Other Study ID Numbers  ICMJE A8501004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement 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 September 2009

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