Clinical trial NCT00321308: Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 110 Events
Secondary outcomes:
measure: Overall Survival
timeFrame: Time of death
measure: Overall Safety Profile
timeFrame: 28 days post treatment
measure: Patient Reported Outcome
timeFrame: End of Treatment
measure: Time to Tumor Progression
timeFrame: End of treatment
measure: Overall Objective Response Rate
timeFrame: Time of disease progressive disease
measure: Duration of Response
timeFrame: Time of disease progression
Other outcomes:
Locations:
city: Litchfield Park
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sun City
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Bentonville
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Fayetteville
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Hudson
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Mahwah
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Midland Park
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Paramus
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Westwood
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Oneida
country: United States
facility: Pfizer Investigational Site
state: New York
city: Oswego
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Sylvania
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Grosshansdorf
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: