E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: eribulin mesylate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a Taxane|
- Objective Response Rate (CR or PR) According to RECIST Criteria [ Time Frame: Tumor measurements repeated every 6 weeks ] [ Designated as safety issue: No ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: 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
- Overall Survival [ Time Frame: From start of treatment to death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]Will be estimated using the product-limit method of Kaplan and Meier.
- Progression Free Survival [ Time Frame: From start of treatment to the time of documented progression, assessed up to 5 years ] [ Designated as safety issue: No ]Will be estimated using the product-limit method of Kaplan and Meier.
|Study Start Date:||November 2006|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: eribulin mesylate
I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer.
II. Evaluate the time to progression and overall survival of patients treated with this drug.
III. Evaluate the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed once monthly for at least 6 months and then periodically thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400829
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Barbara Gitlitz||City of Hope|