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

This study has been completed.
Sponsor:
Collaborator:
Kentucky Lung Cancer Research Program
Information provided by (Responsible Party):
Susanne Arnold, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00247416
First received: October 28, 2005
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Stage IV Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Drug: Gemcitabine
Drug: Dexamethasone
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Percentage of Participants With Reduction in Grade 3/4 Neutropenia [ Time Frame: continuous throughout treatment, up to 25 weeks ] [ Designated as safety issue: Yes ]
    Reduction grade 3/4 neutropenia


Secondary Outcome Measures:
  • Effect of Dexamethasone Pre-treatment on Response Rate. [ Time Frame: Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment ] [ Designated as safety issue: No ]
    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. [ Time Frame: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days ] [ Designated as safety issue: No ]
    Overall survival

  • 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 ] [ Designated as safety issue: No ]
    progression-free survival


Enrollment: 60
Study Start Date: August 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 No Dex
No Dexamethasone
Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
Other Name: 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 Name: Gemzar
Drug: Dexamethasone
16 mg bid for 4 days prior to each chemotherapy start.
Drug: Carboplatin
AUC 6.0 intravenously over 30 minutes on day 5.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247416

Locations
United States, Kentucky
Commonwealth Cancer Center
Danville, Kentucky, United States, 40422
Markey Cancer Center
Lexington, Kentucky, United States, 40536
Brown Cancer Center
Louisville, Kentucky, United States, 40202
St. Claire Regional Medical Center
Morehead, Kentucky, United States, 40351
Montgomery Cancer Center
Mt. Sterling, Kentucky, United States, 40353
Owensboro Medical HealthCare System
Owensboro, Kentucky, United States, 42303
West Kentucky Hematology & Oncology Group, PSC
Paducah, Kentucky, United States, 42003
Sponsors and Collaborators
Susanne Arnold
Kentucky Lung Cancer Research Program
Investigators
Principal Investigator: John Rinehart Lucille P. Markey Cancer Center at University of Kentucky
  More Information

Publications:
Responsible Party: Susanne Arnold, Sponsor/Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT00247416     History of Changes
Other Study ID Numbers: CTN-0501
Study First Received: October 28, 2005
Results First Received: August 2, 2013
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Untreated
Lung
Cancer
non-small cell
gemcitabine
gemzar
carboplatin
dexamethasone

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pleural Effusion
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Gemcitabine
Carboplatin
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 18, 2014