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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006370
  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
Drug: yttrium Y 90-edotreotide
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Lung Cancer   

ChemIDplus related topics:   Octreotide    Octreotide acetate    Somatostatin    Edotreotide    Pentetreotide    Indium in 111 pentetreotide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 2000

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

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
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Larry K. Kvols, MD     H. Lee Moffitt Cancer Center and Research Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068243, MCC-12338, MCC-IRB-5803, NOVARTIS-CSMT-487A0103, NCI-G00-1858
First Received:   October 4, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006370
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer  
recurrent breast cancer  
recurrent small cell lung cancer  
male breast cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Skin Diseases
Carcinoma, Neuroendocrine
Octreotide
Breast Neoplasms
Somatostatin
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Breast Neoplasms, Male
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Lung Diseases
Neuroepithelioma
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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