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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Dexamethasone
Carboplatin
Sponsored by
Susanne Arnold
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Non-small Cell Lung Cancer focused on measuring Untreated, Lung, Cancer, non-small cell, gemcitabine, gemzar, carboplatin, dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Commonwealth Cancer Center
  • Markey Cancer Center
  • Brown Cancer Center
  • St. Claire Regional Medical Center
  • Montgomery Cancer Center
  • Owensboro Medical HealthCare System
  • West Kentucky Hematology & Oncology Group, PSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

1 No Dex

2 Dex

Arm Description

No Dexamethasone

Dexamethasone

Outcomes

Primary Outcome Measures

Percentage of Participants With Reduction in Grade 3/4 Neutropenia
Reduction grade 3/4 neutropenia

Secondary Outcome Measures

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.
Effect of Dexamethasone Pre-treatment on Overall Survival.
Overall survival
Progression-free Survival
progression-free survival

Full Information

First Posted
October 28, 2005
Last Updated
January 16, 2014
Sponsor
Susanne Arnold
Collaborators
Kentucky Lung Cancer Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT00247416
Brief Title
Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer
Official Title
Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susanne Arnold
Collaborators
Kentucky Lung Cancer Research Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Keywords
Untreated, Lung, Cancer, non-small cell, gemcitabine, gemzar, carboplatin, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 No Dex
Arm Type
Other
Arm Description
No Dexamethasone
Arm Title
2 Dex
Arm Type
Experimental
Arm Description
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
16 mg bid for 4 days prior to each chemotherapy start.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
AUC 6.0 intravenously over 30 minutes on day 5.
Primary Outcome Measure Information:
Title
Percentage of Participants With Reduction in Grade 3/4 Neutropenia
Description
Reduction grade 3/4 neutropenia
Time Frame
continuous throughout treatment, up to 25 weeks
Secondary Outcome Measure Information:
Title
Effect of Dexamethasone Pre-treatment on Response Rate.
Description
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.
Time Frame
Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment
Title
Effect of Dexamethasone Pre-treatment on Overall Survival.
Description
Overall survival
Time Frame
Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
Title
Progression-free Survival
Description
progression-free survival
Time Frame
Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Rinehart
Organizational Affiliation
Lucille P. Markey Cancer Center at University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Commonwealth Cancer Center
City
Danville
State/Province
Kentucky
ZIP/Postal Code
40422
Country
United States
Facility Name
Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
St. Claire Regional Medical Center
City
Morehead
State/Province
Kentucky
ZIP/Postal Code
40351
Country
United States
Facility Name
Montgomery Cancer Center
City
Mt. Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Owensboro Medical HealthCare System
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
West Kentucky Hematology & Oncology Group, PSC
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23475103
Citation
Rinehart J, Arnold S, Kloecker G, Lim A, Zaydan MA, Baeker T, Maheshwari JG, Carloss H, Slone S, Shelton B, Croley J, Kvale E, Brooks M, Leggas M. Phase II randomized trial of carboplatin and gemcitabine with or without dexamethasone pre-treatment in patients with Stage IV non-small cell lung cancer. Cancer Chemother Pharmacol. 2013 May;71(5):1375-83. doi: 10.1007/s00280-013-2111-3. Epub 2013 Mar 9.
Results Reference
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Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer

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