Status: Closed
Activation Date: 2000APR04
Closing Date: 2002MAY20
Phase: III
Description: A Phase II/III Double Blind Randomized Trial of BMS-275291 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy For the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
Eligibility: Histologically or cytologically confirmed diagnosis of non-small cell carcinoma of the lung. Cytologic specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable. Patients with Stage IIIB or Stage IV NSCLC, or local or metastatic failure after surgery and/or radiotherapy are eligible. Patients with Stage IIIB NSCLC without pleural effusion who are not candidates for combined modality treatment or who are being treated at centres where combined modality treatment is not the standard of practice are also eligible.
Objective: Phase II - To evaluate the incidence of grade 2 or higher drug related arthritis, arthralgia and/or myalgia in each arm - To estimate the objective tumour response rate in each arm - To evaluate the nature, severity, and frequency of toxicities Phase III Primary Objective: - To compare overall survival (OS) between the 2 arms Secondary Objectives: - To compare progression-free survival (PFS) - To compare response rates (RR) - To estimate time to response and response duration - To compare the nature, severity, and frequency of toxicities between the 2 arms - To correlate the expression of tissue MMP levels (at diagnosis) with outcomes and response to treatment - To correlate serum/plasma MMPs and other markers with outcomes and response to treatment - To compare Quality of Life between the 2 arms - To collect and compare resource utilization for a health economic analysis in North American centres between the 2 treatment arms
Participation: Limited to European and North American Centres
Lay Description: The proposed study examines whether combining best standard care with an agent such as BMS-275291, with a novel mechanism of action and non-overlapping toxicities would improve survival in this group of patients.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| LUNG | BR18 | 774 | 165 | 236 | 262 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| LUNG | BR18 | 774 | 2 | 60 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| LUNG | BR18 | 774 | 0 | 0 | 0 | 0 | 20 | 439 | 0 | 0 |