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

Sponsor:	Pfizer
Information provided by (Responsible Party):	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 (Figitumumab) Drug: Carboplatin Drug: Paclitaxel	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 ]

Enrollment:	681
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2012
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

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

Arms

Assigned Interventions

Experimental: A

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 (Figitumumab)

CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). 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: Carboplatin

Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. 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: Paclitaxel

Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.

Active Comparator: B

Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.

Drug: Carboplatin

Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.

Drug: Paclitaxel

Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.

Detailed Description:

The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

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

Show 279 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
ClinicalTrials.gov Identifier:	NCT00596830 History of Changes
Other Study ID Numbers:	A4021016
Study First Received:	January 3, 2008
Last Updated:	January 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

IGF-1R inhibitor
Non-small-cell lung carcinoma
CP-751
871

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Carcinoma, Adenosquamous
Carcinoma, Large Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Neoplasms, Complex and Mixed
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012