Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

NCT ID: NCT00150657

Last Updated: 2005-11-29

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

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* this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added
* the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen)
* all patients receive all three drugs; there is no placebo

Detailed Description

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* Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible.
* Patients with brain metastases, squamous histology, or hemoptysis are excluded.
* All patients must give informed consent.
* Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bevacizumab

Intervention Type DRUG

carboplatin

Intervention Type DRUG

gemcitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy
* Stage IV disease or stage IIIB with a malignant pleural effusion
* measurable or evaluable disease
* Performance status 0 or 1 (ECOG)
* adequate renal, hepatic, and bone marrow function
* adequate recovery from previous surgery or radiotherapy
* informed consent

Exclusion Criteria

* brain metastases
* squamous (epidermoid) histology
* hemoptysis
* central airway disease
* Pancoast tumors
* previous chemotherapy or biologic therapy for lung cancer
* prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS
* pregnant or nursing women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

St. John Providence Health System

OTHER

Sponsor Role lead

Principal Investigators

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Michael J Kraut, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Cancer Institute

Locations

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Providence Cancer Institute

Southfield, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael J Kraut, MD

Role: CONTACT

Phone: 248-849-3541

Email: [email protected]

Jaswinder Grewal, PhD

Role: CONTACT

Phone: 248-849-5337

Email: [email protected]

Facility Contacts

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Michael J Kraut, MD

Role: primary

Howard Terebelo, DO

Role: backup

Other Identifiers

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AVF3121s

Identifier Type: -

Identifier Source: org_study_id