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Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer

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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small Cell Lung Drug: pemetrexed Drug: pemetrexed + PF-3512676 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: B
Standard of care chemotherapy
 Drug: pemetrexed
500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
Other Name: Alimta
Experimental: A
Standard of care chemotherapy plus experimental intervention (PF-3512676)
 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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 110 Events ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Time of death ]
  2. Overall Safety Profile [ Time Frame: 28 days post treatment ]
  3. Patient Reported Outcome [ Time Frame: End of Treatment ]
  4. Time to Tumor Progression [ Time Frame: End of treatment ]
  5. Overall Objective Response Rate [ Time Frame: Time of disease progressive disease ]
  6. Duration of Response [ Time Frame: Time of disease progression ]

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:

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

Exclusion Criteria:

  • Known CNS metastasis
  • Pre-existing autoimmune or antibody mediated disease
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): NCT00321308


Locations
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United States, Arizona
Pfizer Investigational Site
Litchfield Park, Arizona, United States, 85340
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
United States, Arkansas
Pfizer Investigational Site
Bentonville, Arkansas, United States, 72712
Pfizer Investigational Site
Fayetteville, Arkansas, United States, 72703
United States, Florida
Pfizer Investigational Site
Hudson, Florida, United States, 34667
Pfizer Investigational Site
New Port Richey, Florida, United States, 34655
United States, New Jersey
Pfizer Investigational Site
Mahwah, New Jersey, United States, 07430
Pfizer Investigational Site
Midland Park, New Jersey, United States, 07432
Pfizer Investigational Site
Paramus, New Jersey, United States, 07652
Pfizer Investigational Site
Westwood, New Jersey, United States, 07675
United States, New York
Pfizer Investigational Site
Oneida, New York, United States, 13421
Pfizer Investigational Site
Oswego, New York, United States, 13126
Pfizer Investigational Site
Syracuse, New York, United States, 13210-2306
Pfizer Investigational Site
Syracuse, New York, United States, 13210
United States, Ohio
Pfizer Investigational Site
Sylvania, Ohio, United States, 43560
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 89109
Pfizer Investigational Site
Seattle, Washington, United States, 98195
Germany
Pfizer Investigational Site
Grosshansdorf, Germany, 22927
Pfizer Investigational Site
Mannheim, Germany, 68167
Italy
Pfizer Investigational Site
Torino, Italy, 10126
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00321308    
Other Study ID Numbers: A8501004
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: September 28, 2009
Last Verified: September 2009
Keywords provided by Pfizer:
advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors