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

This study has been terminated.
(See Termination Reason in Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00254891
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 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 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 Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin 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:
  • 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
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

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
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: NCT00254891

  Show 191 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: NCT00254891     History of Changes
Other Study ID Numbers: A8501001
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, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014