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

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Small cell or carcinoid lung cancer

- Known Central Nervous System (CNS) metastasis

- Pre-existing auto-immune or antibody mediated diseases

NCT00254904
Pfizer
Terminated
Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

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Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • 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
  • Drug: Gemcitabine + Cisplatin
    Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
    Other Name: Gemzar
  • Experimental: A
    Standard of Care chemotherapy plus experimental intervention (PF-3512676)
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Drug: PF-3512676
  • Active Comparator: B
    Standard of Care chemotherapy
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine + Cisplatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
839
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
France
 
NCT00254904
A8501002
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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