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

NCT ID: NCT00147537

Last Updated: 2013-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2011-08-31

Brief Summary

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Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.

Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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non-small cell lung cancer chemotherapy figitumumab insulin-like growth 1 factor receptor IGF-IR monoclonal antibody

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 2 (Arms A & B)

CP-751,871 + paclitaxel + carboplatin

Group Type EXPERIMENTAL

CP-751,871

Intervention Type DRUG

Phase 2 Arm A:

CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles

paclitaxel

Intervention Type DRUG

Phase 2 Arm A:

Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

Phase 2 Arm B:

Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

carboplatin

Intervention Type DRUG

Phase 2 Arm A:

Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

Phase 2 Arm B:

Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

Phase 1b

1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin
2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib

Group Type EXPERIMENTAL

CP-751,871

Intervention Type DRUG

Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles)

paclitaxel

Intervention Type DRUG

Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles)

carboplatin

Intervention Type DRUG

Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles)

erlotinib

Intervention Type DRUG

Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)

Interventions

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CP-751,871

Phase 2 Arm A:

CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles

Intervention Type DRUG

paclitaxel

Phase 2 Arm A:

Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

Phase 2 Arm B:

Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

Intervention Type DRUG

carboplatin

Phase 2 Arm A:

Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

Phase 2 Arm B:

Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

Intervention Type DRUG

CP-751,871

Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles)

Intervention Type DRUG

paclitaxel

Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles)

Intervention Type DRUG

carboplatin

Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles)

Intervention Type DRUG

erlotinib

Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of advanced/metastatic lung cancer

Exclusion Criteria

* Previous treatment with chemotherapy
* Uncontrolled diabetes
* History/active cardiovascular disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Tucson, Arizona, United States

Site Status

Pfizer Investigational Site

Tucson, Arizona, United States

Site Status

Pfizer Investigational Site

Tucson, Arizona, United States

Site Status

Pfizer Investigational Site

Greenbrae, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Jacksonville, Florida, United States

Site Status

Pfizer Investigational Site

Jacksonville, Florida, United States

Site Status

Pfizer Investigational Site

Jeffersonville, Indiana, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Shelbyville, Kentucky, United States

Site Status

Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

Rochester, Minnesota, United States

Site Status

Pfizer Investigational Site

Corinth, Mississippi, United States

Site Status

Pfizer Investigational Site

Southaven, Mississippi, United States

Site Status

Pfizer Investigational Site

City of Saint Peters, Missouri, United States

Site Status

Pfizer Investigational Site

Creve Coeur, Missouri, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

The Bronx, New York, United States

Site Status

Pfizer Investigational Site

The Bronx, New York, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Orbassano (TO), , Italy

Site Status

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Seville, Sevilla, Spain

Site Status

Countries

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United States Canada Italy Spain

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021002&StudyName=Combination%20Study%20Of%20CP-751%2C871%20With%20Paclitaxel%20And%20Carboplatin%20In%20Advanced%20Lung%20Cancer

To obtain contact information for a study center near you, click here.

Other Identifiers

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A4021002

Identifier Type: -

Identifier Source: org_study_id