Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00596830

Purpose

Determine whether the addition of CP 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

Condition	Intervention	Phase
Carcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma, Large Cell Carcinoma, Non-Small-Cell Lung	Drug: CP-751,871 + Carboplatin +Paclitaxel Drug: Carboplatin + Paclitaxel	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Insulin-like growth factor I Mecasermin rinfabate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall Survival (OS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall objective response rate (ORR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Progression Free Survival (PFS) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Overall safety profile [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Patient reported outcomes (PROs) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Pharmacokinetics of CP 751,871 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Anti drug antibody occurrence [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Change in serum IGF1 levels [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	820
Study Start Date:	March 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.`	Drug: CP-751,871 + Carboplatin +Paclitaxel CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer.
B: Active Comparator Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.	Drug: Carboplatin + Paclitaxel Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer

Eligibility

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

Criteria

Inclusion Criteria:

Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
ECOG performance status (PS) 0 or 1.

Exclusion Criteria:

Patients with symptomatic central nervous system (CNS) metastases are not permitted.
Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
Patients with other active cancer types are not permitted.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596830

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 343 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4021016
Study First Received:	January 3, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00596830 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

IGF-1R inhibitor, Non-small-cell lung carcinoma, CP-751871

Study placed in the following topic categories:

Thoracic Neoplasms
Antimitotic Agents
Carboplatin
Insulin
Carcinoma
Antibodies, Monoclonal
Antibodies
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Lung Diseases

Tubulin Modulators
Carcinoma, Large Cell
Mitogens
Non-small Cell Lung Cancer
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Carcinoma, Adenosquamous
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Squamous Cell
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Carboplatin
Antimitotic Agents

Pharmacologic Actions
Carcinoma
Neoplasms
Paclitaxel
Lung Diseases
Carcinoma, Large Cell
Tubulin Modulators
Carcinoma, Squamous Cell
Antineoplastic Agents, Phytogenic
Carcinoma, Adenosquamous
Carcinoma, Non-Small-Cell Lung
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009