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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00254891
Recruitment Status : Terminated (See Termination Reason in Detailed Description)
First Posted : November 17, 2005
Last Update Posted : March 30, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: PF-3512676 + Paclitaxel + Carboplatin Drug: Paclitaxel + Carboplatin Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 828 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2005
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
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.
Other Name: Taxol; Paraplatin
Active Comparator: B
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.
Other Name: Taxol; Paraplatin


Outcome Measures

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 656 Events ]

Secondary Outcome Measures :
  1. Overall Objective Response [ Time Frame: End of Treatment ]
  2. Time to Tumor Progression [ Time Frame: Time of progressive disease ]
  3. Progression Free Survival [ Time Frame: Time of primary endpoint ]
  4. Duration of Response [ Time Frame: Time of progressive disease ]
  5. Patient Reported Outcomes [ Time Frame: End of Treatment ]
  6. Overall Safety Profile [ Time Frame: 28 days post PF-3512676 dosing ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254891


  Show 191 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00254891     History of Changes
Other Study ID Numbers: A8501001
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Keywords provided by Pfizer:
advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action