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

This study has been terminated.
(See Termination Reason in Detailed Description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00321308
First received: May 2, 2006
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Carcinoma, Non-Small Cell Lung
Drug: pemetrexed
Drug: pemetrexed + PF-3512676
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 110 Events ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Time of death ] [ Designated as safety issue: No ]
  • Overall Safety Profile [ Time Frame: 28 days post treatment ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcome [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
  • Time to Tumor Progression [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Overall Objective Response Rate [ Time Frame: Time of disease progressive disease ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Time of disease progression ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321308

Locations
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
Pfizer Investigational Site
Syracuse, New York, United States, 13210-2306
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
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00321308     History of Changes
Other Study ID Numbers: A8501004
Study First Received: May 2, 2006
Last Updated: September 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014