Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

NCT ID: NCT00907504

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-05-31

Brief Summary

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Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

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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CP-751,871 + Gemcitabine + Cisplatin

investigational arm

Group Type EXPERIMENTAL

CP-751,871

Intervention Type DRUG

CP-751,871 20mg/kg every 3 weeks

Cisplatin

Intervention Type DRUG

Cisplatin 80 mg/m2 every 3 weeks

Gemcitabine

Intervention Type DRUG

Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle

Gemcitabine + Cisplatin

standard of care

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Cisplatin 80 mg/m2 every 3 weeks

Gemcitabine

Intervention Type DRUG

Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle

Interventions

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CP-751,871

CP-751,871 20mg/kg every 3 weeks

Intervention Type DRUG

Cisplatin

Cisplatin 80 mg/m2 every 3 weeks

Intervention Type DRUG

Gemcitabine

Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle

Intervention Type DRUG

Cisplatin

Cisplatin 80 mg/m2 every 3 weeks

Intervention Type DRUG

Gemcitabine

Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
* Male or female \> 18 years
* Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
* Adequate organ function

Exclusion Criteria

* Uncontrolled hypertension or diabetes;
* Pregnant female;
* Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.
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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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

Other Identifiers

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A4021017

Identifier Type: -

Identifier Source: org_study_id

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