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

Phase 2

Completed

• Conditions: Stage IV Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer
• Interventions: Drug: Gemcitabine; Drug: Carboplatin; Drug: Dexamethasone

• Registration Number: NCT00247416
• Lead Sponsor: Susanne Arnold

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-10-28
• Study First Submitted QC: 2005-10-28
• Study First Posted: 2005-11-01
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2013-08-02
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-16
• Last Update Submitted: 2014-01-16
• Results First Posted: 2014-03-07
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 No Dex	Gemcitabine	No Dexamethasone
1 No Dex	Carboplatin	No Dexamethasone
2 Dex	Gemcitabine	Dexamethasone
2 Dex	Carboplatin	Dexamethasone
2 Dex	Dexamethasone	Dexamethasone

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Reduction in Grade 3/4 Neutropenia	continuous throughout treatment, up to 25 weeks	Reduction grade 3/4 neutropenia

Secondary Outcome Measures

Name	Time	Method
Effect of Dexamethasone Pre-treatment on Response Rate.	Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment	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.
Effect of Dexamethasone Pre-treatment on Overall Survival.	Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days	Overall survival
Progression-free Survival	Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days	progression-free survival

Trial Locations

Locations (7)

Markey Cancer Center; 🇺🇸 Lexington, Kentucky, United States

St. Claire Regional Medical Center; 🇺🇸 Morehead, Kentucky, United States

Commonwealth Cancer Center; 🇺🇸 Danville, Kentucky, United States

Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Montgomery Cancer Center; 🇺🇸 Mt. Sterling, Kentucky, United States

West Kentucky Hematology & Oncology Group, PSC; 🇺🇸 Paducah, Kentucky, United States

Owensboro Medical HealthCare System; 🇺🇸 Owensboro, Kentucky, United States