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

January 16, 2014 updated by: Susanne Arnold

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Danville, Kentucky, United States, 40422
        • Commonwealth Cancer Center
      • Lexington, Kentucky, United States, 40536
        • Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • Brown Cancer Center
      • Morehead, Kentucky, United States, 40351
        • St. Claire Regional Medical Center
      • Mt. Sterling, Kentucky, United States, 40353
        • Montgomery Cancer Center
      • Owensboro, Kentucky, United States, 42303
        • Owensboro Medical HealthCare System
      • Paducah, Kentucky, United States, 42003
        • West Kentucky Hematology & Oncology Group, PSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Reduction in Grade 3/4 Neutropenia
Time Frame: continuous throughout treatment, up to 25 weeks
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.
Time Frame: 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.
Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment
Effect of Dexamethasone Pre-treatment on Overall Survival.
Time Frame: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
Overall survival
Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
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
progression-free survival
Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Susanne Arnold

Collaborators

Kentucky Lung Cancer Research Program

Investigators

  • Principal Investigator: John Rinehart, Lucille P. Markey Cancer Center at University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (Estimate)

November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTN-0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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