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

This study has been terminated.
(See Termination Reason in Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00254904
First received: November 15, 2005
Last updated: September 24, 2009
Last verified: September 2009
  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 3

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


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
Experimental: A
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
Other Name: Platinol-AQ
Drug: Gemcitabine
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
Other Name: Gemzar
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
Active Comparator: B
Standard of Care chemotherapy
Drug: Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
Other Name: Platinol-AQ
Drug: Gemcitabine + Cisplatin
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
Other Name: Gemzar

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00254904     History of Changes
Other Study ID Numbers: A8501002
Study First Received: November 15, 2005
Last Updated: September 24, 2009
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 20, 2014