Status: Closed
Activation Date: 2009JAN30
Closing Date: 2011MAR10
Phase: I-II
Description: A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination with Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer.
Eligibility: Patients with histologically confirmed, extensive stage small cell lung cancer. No prior chemotherapy for SCLC. Prior radiation permitted to brain but not to lung. No uncontrolled diabetes or cardiac conditions and acceptable end-organ function. ECOG 0, 1 or 2. Unidimensionally measurable disease.
Objective: 1.1 Phase I Objectives 1.1.1 To determine the recommended phase II dose of MK-0646 in combination with a standard etoposide and cisplatin (EP) chemotherapy regimen. 1.1.2 Evaluate the toxicity and preliminary efficacy of the combination. 1.2 Phase II Objectives 1.2.1 To assess the efficacy, as determined by objective response rate; including complete response rate, progression-free survival and overall survival. 1.2.2 To assess the toxicity and tolerability. 1.2.3 Explore the predictive and prognostic impact of biomarkers.
Participation: Limited to invited centres
Lay Description: The main purpose of the phase I portion of the study is to find out which dose of MK-0646 is safe to give with standard cisplatin/etopside to patients with extensive stage small cell lung cancer. In the phase II portion, researchers will also look at what effect it has on small cell lung cancer by seeing if it makes the lesions shrink and if it changes the tumour markers. Additional research will investigate tissue samples from previously removed small cell lung cancer tumour.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I190 | 12 | 6 | 2 | 8 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I190 | 12 | 0 | 0 |
| 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 |
| IND | I190 | 12 | 10 | 0 | 0 | 0 | 0 | 12 | 0 | 0 |