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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Larry K. Kvols, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

NOVARTIS-CSMT-487A0103

NCT ID:

NCT00006370

Start Date:

July 2000

Completion Date:

June 2004

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • recurrent small cell lung cancer
  • male breast cancer
  • Breast Neoplasms
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612