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

Carcinoma, Non-Small Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00321308
• Other study ID #: A8501004
• Status: Terminated
• Phase: Phase 2
• First received: May 2, 2006
• Last updated: September 24, 2009
• Start date: September 2006
• Est. completion date: January 2008

Study information

• Verified date: September 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• pemetrexed
500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
• pemetrexed + PF-3512676
pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Grosshansdorf
Germany	Pfizer Investigational Site	Mannheim
Italy	Pfizer Investigational Site	Torino
United States	Pfizer Investigational Site	Bentonville	Arkansas
United States	Pfizer Investigational Site	Fayetteville	Arkansas
United States	Pfizer Investigational Site	Hudson	Florida
United States	Pfizer Investigational Site	Litchfield Park	Arizona
United States	Pfizer Investigational Site	Mahwah	New Jersey
United States	Pfizer Investigational Site	Midland Park	New Jersey
United States	Pfizer Investigational Site	New Port Richey	Florida
United States	Pfizer Investigational Site	Oneida	New York
United States	Pfizer Investigational Site	Oswego	New York
United States	Pfizer Investigational Site	Paramus	New Jersey
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Sun City	Arizona
United States	Pfizer Investigational Site	Sylvania	Ohio
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Westwood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		110 Events	No
Secondary	Overall Survival		Time of death	No
Secondary	Overall Safety Profile		28 days post treatment	Yes
Secondary	Patient Reported Outcome		End of Treatment	No
Secondary	Time to Tumor Progression		End of treatment	No
Secondary	Overall Objective Response Rate		Time of disease progressive disease	No
Secondary	Duration of Response		Time of disease progression	No

External Links

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