Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00147537

Purpose

To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: CP-751,871 + paclitaxel + carboplatin Drug: CP-751,871 + paclitaxel + carboplatin + erlotinib	Phase I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Phase 1b Dose Escalation/Phase 2 Randomized, Non-Comparative, Multiple Center, Open Label Study Of CP 751,871 In Combination With Paclitaxel And Carboplatin And Of Paclitaxel And Carboplatin Alone As First Line Treatment For Advanced Non-Small Cell Lung Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

Antitumor efficacy measured as Objective Responses using RECIST criteria. [ Time Frame: December 2008, about 9 months from the last enrolled patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety,pharmacokinetics,pharmacodynamics of CP-751,871/paclitaxel/ carboplatin [ Time Frame: December 2008, about 9 months from the last enrolled patient ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	February 2005
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase 2 Arm A/Phase 2 Arm B: Experimental	Drug: CP-751,871 + paclitaxel + carboplatin Phase 2 Arm A only:CP‑751,871 20 mg/kg IV over 2.5 hours up to 17 cycles
Phase 1b/Phase 1b Extension: Experimental	Drug: CP-751,871 + paclitaxel + carboplatin + erlotinib Phase 1b and Phase 1b extension: CP‑751,871 20 mg/kg IV over 2.5 hours up to 17 cycles

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of advanced/metastatic lung cancer

Exclusion Criteria:

Previous treatment with chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147537

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 30 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:	A4021002
Study First Received:	September 2, 2005
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00147537
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Erlotinib
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