Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00254904

Purpose

To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of gemcitabine/cisplatin alone.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Cisplatin Drug: Gemcitabine Drug: PF-3512676 Drug: Gemcitabine + Cisplatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall Survival [ Time Frame: 656 Events ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Reported Outcomes [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Overall Safety Profile [ Time Frame: 28 days post PF03512676 dosing ] [ Designated as safety issue: Yes ]
Progression Free Survival [ Time Frame: Time of primary endpoint ] [ Designated as safety issue: No ]
Time to Tumor Progression [ Time Frame: Time of progressive disease ] [ Designated as safety issue: No ]
Overall Objective Response [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: Time of progressive disease ] [ Designated as safety issue: No ]

Enrollment:	839
Study Start Date:	November 2005
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Standard of Care chemotherapy plus experimental intervention (PF-3512676)	Drug: Cisplatin Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles Drug: Gemcitabine Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles Drug: PF-3512676 PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
B: Active Comparator Standard of Care chemotherapy	Drug: Cisplatin Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles Drug: Gemcitabine + Cisplatin Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles

Detailed Description:

PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (thrombocytopenia) also contributing to the decision.

Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

Small cell or carcinoid lung cancer
Known Central Nervous System (CNS) metastasis
Pre-existing auto-immune or antibody mediated diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254904

Show 121 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8501002
Study First Received:	November 15, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00254904 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

advanced carcinoma, non-small cell lung, Phase III, Gemcitabine, Gemzar, Cisplatin, Platinol, PF-3512676, immunotherapy, immune modulator

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Respiratory Tract Diseases

Cisplatin
Radiation-Sensitizing Agents
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses

Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009