Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00254891

Purpose

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin 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 paclitaxel

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

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Overall Objective Response [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
Time to Tumor Progression [ Time Frame: Time of progressive disease ] [ Designated as safety issue: No ]
Progression Free Survival [ Time Frame: Time of primary endpoint ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: Time of progressive disease ] [ Designated as safety issue: No ]
Patient Reported Outcomes [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
Overall Safety Profile [ Time Frame: 28 days post PF-3512676 dosing ] [ Designated as safety issue: Yes ]

Enrollment:	828
Study Start Date:	November 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Standard of care chemotherapy plus experiment intervention (PF-3512676)	Drug: PF-3512676 + Paclitaxel + Carboplatin PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity. Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
B: Active Comparator Standard of care chemotherapy	Drug: Paclitaxel + Carboplatin Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. Carboplatin: AUC 6 intravenously Day 1 of each 21 days 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 (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 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 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: NCT00254891

Show 191 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8501001
Study First Received:	November 15, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00254891
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009