Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer.

This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.

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Detailed Description

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Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment.

Conditions

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Stage IV Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer

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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1 No Dex

No Dexamethasone

Group Type OTHER

Gemcitabine

Intervention Type DRUG

Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.

Carboplatin

Intervention Type DRUG

AUC 6.0 intravenously over 30 minutes on day 5.

2 Dex

Dexamethasone

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.

Dexamethasone

Intervention Type DRUG

16 mg bid for 4 days prior to each chemotherapy start.

Carboplatin

Intervention Type DRUG

AUC 6.0 intravenously over 30 minutes on day 5.

Interventions

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Gemcitabine

Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.

Intervention Type DRUG

Dexamethasone

16 mg bid for 4 days prior to each chemotherapy start.

Intervention Type DRUG

Carboplatin

AUC 6.0 intravenously over 30 minutes on day 5.

Intervention Type DRUG

Other Intervention Names

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Gemzar

Eligibility Criteria

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Inclusion Criteria

* Untreated, stage IIIB with pleural effusion
* Untreated, Stage IV, non-small cell lung cancer
* Recurrent after surgery if no previous radiation therapy or chemotherapy were administered as part of their primary treatment, except for palliative radiotherapy
* 18 years of age or older
* ECOG PS 0, 1 or 2
* At Least one target lesion according to the RECIST Criteria
* Adequate organ and marrow function

Exclusion Criteria

* Previous cancer history unless they have had curative treatment completed at least 5 years prior to entry.
* No previous radiotherapy, chemotherapy or immunotherapy for NSCLC, except for radiation therapy to the brain to control metastasis, bone to control pain, or lung to relieve bronchial obstruction.
* No radiation therapy for any previous cancer to more than 25% of bone marrow.
* Uncontrolled, intercurrent illness
* Non-study corticosteroids
* Pregnant women
* Peripheral neuropathy greater than grade 1
* Uncontrolled seizures, central nervous system disorders
* Major surgery within 4 weeks of the start of study treatment
* Lack of complete recovery from major surgery.
* Glaucoma
* Lack of physical integrity of upper gastrointestinal tract, inability to swallow tablets
* Severe acquired or hereditary immunodeficiency
* Patients with brain metastases must receive definitive treatment (radiation, surgery or both) and be clinically and radiologically stable for 4 weeks \& off corticosteroids for at least 2 weeks prior to randomization.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No