Radiolabeled SMT-487 (Yttrium Y 90-DOTA-tyr3-octreotide) in Treating Patients With Refractory Small Cell Lung Cancer or Metastatic Breast Cancer
RATIONALE: Radiolabeled drugs such as yttrium Y 90-DOTA-tyr3-octreotide can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of yttrium Y 90-DOTA-tyr3-octreotide in treating patients who have refractory small cell lung cancer or metastatic breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II, Open-label, Multi-Center Study to Evaluate the Efficacy of 90Y-SMT 487 Administered Intravenously to Patients With Refractory Small Cell Lung or Advanced Metastatic Breast Cancer Expressing Somatostatin Receptors as Determined by OctreoScan Scintigraphy|
|Study Start Date:||July 2000|
|Study Completion Date:||June 2004|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the tumor response rate of yttrium Y 90 SMT 487 in patients with refractory small cell lung cancer or advanced metastatic breast cancer expressing somatostatin receptor. II. Determine the safety of this treatment regimen in these patients. III. Determine the overall survival of these patients with this treatment regimen. IV. Determine the quality of life in these patients with this treatment regimen. V. Determine the frequency of tumors which are positive (3+ or 4+) for OctreoScan scintigraphy in this patient population.
OUTLINE: This is a multicenter study. Patients receive yttrium Y 90 SMT 487 IV over 10-15 minutes on day 1. Treatment repeats every 6-9 weeks for up to 3 courses in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline and at course 3, week 6. Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006370
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Larry K. Kvols, MD||H. Lee Moffitt Cancer Center and Research Institute|