Clinical trial NCT00247416: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Kentucky Lung Cancer Research Program
First posted: 2005-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants With Reduction in Grade 3/4 Neutropenia
timeFrame: continuous throughout treatment, up to 25 weeks
Secondary outcomes:
measure: Effect of Dexamethasone Pre-treatment on Response Rate.
timeFrame: Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment
measure: Effect of Dexamethasone Pre-treatment on Overall Survival.
timeFrame: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
measure: Progression-free Survival
timeFrame: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days
Other outcomes:
Locations:
city: Danville
country: United States
facility: Commonwealth Cancer Center
state: Kentucky
city: Lexington
country: United States
facility: Markey Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Brown Cancer Center
state: Kentucky
city: Morehead
country: United States
facility: St. Claire Regional Medical Center
state: Kentucky
city: Mt. Sterling
country: United States
facility: Montgomery Cancer Center
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Medical HealthCare System
state: Kentucky
city: Paducah
country: United States
facility: West Kentucky Hematology & Oncology Group, PSC
state: Kentucky
Study officials:
affiliation: Lucille P. Markey Cancer Center at University of Kentucky
name: John Rinehart
role: PRINCIPAL_INVESTIGATOR
References:
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.