Radiolabeled SMT-487 (Yttrium Y 90-DOTA-tyr3-octreotide) in Treating Patients With Refractory Small Cell Lung Cancer or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00006370
First received: October 4, 2000
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Lung Cancer
Radiation: yttrium Y 90-edotreotide
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Enrollment: 275
Study Start Date: July 2000
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed small cell lung cancer Must have received one prior chemotherapy regimen and relapsed OR Diagnosis of metastatic breast cancer No more than two prior chemotherapy regimens for metastatic disease Measurable disease Prior radiotherapy to measurable lesion allowed if progressed since treatment No diffuse bone marrow involvement on OctreoScan scintigraphy Positive for somatostatin receptors (grade 3 or 4) by Octreoscan scintigraphy No unstable brain metastases within the past 6 months Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not specified Performance status: Small cell lung cancer patients: Karnofsky 80-100% Breast cancer patients: Karnofsky 50-100% Life expectancy: Greater than 12 weeks Hematopoietic: Hemoglobin at least 8 g/dL Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 5 times ULN Renal: Creatinine no greater than 1.7 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No history of congestive heart failure unless ejection fraction at least 40% Other: No other significant, uncontrolled medical, psychiatric, or surgical condition that would preclude study Not pregnant No nursing during and for 1 month following study Negative pregnancy test Fertile patients must use effective contraception during and for 6 months following study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy No concurrent biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy Concurrent localized radiotherapy allowed provided measurable disease exists outside of the radiation field Surgery: At least 2 weeks since prior surgery Concurrent localized surgery allowed provided measurable disease exists outside of the surgical field Other: At least 4 weeks since other prior investigational therapy No concurrent medication that decreases renal function (e.g., aminoglycoside antibiotics) No other concurrent investigational agent Concurrent bisphosphonates allowed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006370

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Larry K. Kvols, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00006370     History of Changes
Other Study ID Numbers: NOVARTIS-CSMT-487A0103, MCC-12338, MCC-IRB-5803, CDR0000068243, NCI-G00-1858
Study First Received: October 4, 2000
Last Updated: April 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Novartis:
stage IV breast cancer
recurrent breast cancer
recurrent small cell lung cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Small Cell Lung Carcinoma
Breast Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014