NCT00006370

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jul 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 2, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

3.9 years

First QC Date

October 4, 2000

Last Update Submit

April 30, 2013

Conditions

Breast CancerLung Cancer

Keywords

stage IV breast cancerrecurrent breast cancerrecurrent small cell lung cancermale breast cancer

Interventions

yttrium Y 90-edotreotideRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsSmall Cell Lung CarcinomaBreast Neoplasms, Male

Interventions

90Y-octreotide, DOTA-Tyr(3)-

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Larry K. Kvols, MD

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2000

First Posted

April 2, 2004

Study Start

July 1, 2000

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

May 1, 2013

Record last verified: 2013-04

Locations

US(1)