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

Study Overview
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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.

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.

Official Title
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Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer

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

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Dexamethasone
* Drug: Carboplatin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 No Dex<br>No Dexamethasone | Drug: Gemcitabine<br>* Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.<br>* Other names: Gemzar;Drug: Carboplatin<br>* AUC 6.0 intravenously over 30 minutes on day 5.<br>|
| Experimental: 2 Dex<br>Dexamethasone | Drug: Gemcitabine<br>* Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.<br>* Other names: Gemzar;Drug: Dexamethasone<br>* 16 mg bid for 4 days prior to each chemotherapy start.<br>Drug: Carboplatin<br>* AUC 6.0 intravenously over 30 minutes on day 5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Reduction in Grade 3/4 Neutropenia | Reduction grade 3/4 neutropenia | continuous throughout treatment, up to 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Dexamethasone Pre-treatment on Response Rate. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment | 
| Effect of Dexamethasone Pre-treatment on Overall Survival. | Overall survival | Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days | 
| Progression-free Survival | progression-free survival | Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung, Untreated, Cancer, non-small cell, gemcitabine, gemzar, carboplatin, dexamethasone