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

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247416
• Other study ID #: CTN-0501
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2005
• Last updated: January 16, 2014
• Start date: August 2005
• Est. completion date: July 2009

Study information

• Verified date: January 2014
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Pleural Effusion
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Intervention

Drug:
• Gemcitabine
Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
• Dexamethasone
16 mg bid for 4 days prior to each chemotherapy start.
• Carboplatin
AUC 6.0 intravenously over 30 minutes on day 5.

Locations

Country	Name	City	State
United States	Commonwealth Cancer Center	Danville	Kentucky
United States	Markey Cancer Center	Lexington	Kentucky
United States	Brown Cancer Center	Louisville	Kentucky
United States	St. Claire Regional Medical Center	Morehead	Kentucky
United States	Montgomery Cancer Center	Mt. Sterling	Kentucky
United States	Owensboro Medical HealthCare System	Owensboro	Kentucky
United States	West Kentucky Hematology & Oncology Group, PSC	Paducah	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Susanne Arnold	Kentucky Lung Cancer Research Program

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 pati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Reduction in Grade 3/4 Neutropenia	Reduction grade 3/4 neutropenia	continuous throughout treatment, up to 25 weeks	Yes
Secondary	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.	Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment	No
Secondary	Effect of Dexamethasone Pre-treatment on Overall Survival.	Overall survival	Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days	No
Secondary	Progression-free Survival	progression-free survival	Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days	No