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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00321308
First received: May 2, 2006
Last updated: September 24, 2009
Last verified: September 2009
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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
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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013