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

September 24, 2009 updated by: Pfizer

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 110 Events
110 Events

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8501004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Non-Small Cell Lung

Clinical Trials on pemetrexed

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe