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

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

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

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small Cell Lung
• Intervention / Treatment: Drug: pemetrexed; Drug: pemetrexed + PF-3512676

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: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Grosshansdorf, Germany, 22927
    • Pfizer Investigational Site
  • Mannheim, Germany, 68167
    • Pfizer Investigational Site
• Italy
  • Torino, Italy, 10126
    • Pfizer Investigational Site
• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Pfizer Investigational Site
    • Sun City, Arizona, United States, 85351
      • Pfizer Investigational Site
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Pfizer Investigational Site
    • Fayetteville, Arkansas, United States, 72703
      • Pfizer Investigational Site
  • Florida
    • Hudson, Florida, United States, 34667
      • Pfizer Investigational Site
    • New Port Richey, Florida, United States, 34655
      • Pfizer Investigational Site
  • New Jersey
    • 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
      • Pfizer Investigational Site
  • New York
    • 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
      • Pfizer Investigational Site
  • Ohio
    • Sylvania, Ohio, United States, 43560
      • Pfizer Investigational Site
  • Washington
    • Seattle, Washington, United States, 98195
      • Pfizer Investigational Site
    • Seattle, Washington, United States, 89109
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Alimta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	110 Events

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	Time of death
Overall Safety Profile	28 days post treatment
Patient Reported Outcome	End of Treatment
Time to Tumor Progression	End of treatment
Overall Objective Response Rate	Time of disease progressive disease
Duration of Response	Time of disease progression

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: May 2, 2006
• First Submitted That Met QC Criteria: May 2, 2006
• First Posted (Estimate): May 3, 2006

Study Record Updates

• Last Update Posted (Estimate): September 28, 2009
• Last Update Submitted That Met QC Criteria: September 24, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: A8501004