Octreotide and Doxorubicin in Treating Patients With Advanced Cancer
NCT ID: NCT00008073
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1996-01-31
2002-05-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of octreotide and doxorubicin in treating patients who have advanced cancer.
Detailed Description
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OUTLINE: This is a dose escalation study of octreotide. Patients receive doxorubicin IV over 5 minutes on day 1 of course 1. For all subsequent courses, patients receive octreotide SC continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease after 3 courses of therapy receive a maximum of 6 additional courses. Cohorts of 3-6 patients receive escalating doses of octreotide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 21-30 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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doxorubicin hydrochloride
octreotide acetate
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered No more than 240 mg/m2 total cumulative dose of prior doxorubicin Endocrine therapy: Prior octreotide allowed Recovered from prior octreotide Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Laura A. Pollice
Clinical Research Manager
Principal Investigators
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G. S. Long, MD, PhD
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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CDR0000068373
Identifier Type: REGISTRY
Identifier Source: secondary_id
PCI-IRB-951264
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1886
Identifier Type: -
Identifier Source: secondary_id
95-088
Identifier Type: -
Identifier Source: org_study_id