Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer
NCT ID: NCT00562185
Last Updated: 2017-11-20
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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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2008-05-31
2009-03-31
Brief Summary
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PURPOSE: This phase I and phase II trial is studying the side effects and best dose of carboplatin when given together with doxorubicin to see how well it works in treating patients with recurrent ovarian cancer.
Detailed Description
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Primary
* To determine the maximum tolerated dose and safety of intravenous doxorubicin hydrochloride and intraperitoneal carboplatin in patients with platinum-sensitive recurrent ovarian cancer.
* To evaluate the feasibility of this regimen in these patients.
Secondary
* To evaluate the response rate and progression-free survival of patients with recurrent ovarian cancer who have had no more than two prior salvage regimens.
OUTLINE: This is a phase I dose-escalation study of carboplatin followed by a phase II study.
* Phase I: Patients receive doxorubicin hydrochloride IV over 1 hour followed by carboplatin intraperitoneally on day 1 until the maximum tolerated dose is achieved. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
* Phase II: Patients receive doxorubicin hydrochloride as in phase I and carboplatin at the maximum tolerated dose as in phase I.
After completion of study treatment, patients are followed every 4 weeks for 1 year.
PROJECTED ACCRUAL: A total of 61 patients (18 patients in phase I and 43 patients in phase II) will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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carboplatin
doxorubicin hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Life expectancy \> 6 months
* Absolute neutrophil count ≥ 1,500/uL
* Platelet count ≥ 100,000/uL
* Hemoglobin \> 9.0 g/dL
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 1.5 x upper limit of normal (ULN)
* SGOT and alkaline phosphatase ≤ 3 x ULN
* Neuropathy (sensory and motor) ≤ CTCAE grade 1
* See Disease Characteristics
* At least 6 months since prior adjuvant regimen
* At least 4 weeks since prior salvage treatment
* May have received secondary cytoreduction for recurrent ovarian cancer
* May have received prior intraperitoneal therapy for ovarian cancer
* May have received no more than 2 prior platinum and taxane-based regimens
* May have received prior intraperitoneal platinum during front-line treatment
Exclusion Criteria
* Pregnant or breastfeeding
* History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of DOXIL®
* Abnormal LVEF as determined by gated cardiac radionucleotide scan (MUGA)
* Septicemia or severe infection
* Acute hepatitis or severe gastrointestinal bleeding
* Any of the following:
* Unstable angina
* Myocardial infarction within the past 6 months
* NYHA class II-IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* Clinically significant pericardial disease
* Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
* Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months
* Other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
* Prior anthracycline dose exceeding 360 mg/m\^2 for doxorubicin hydrochloride (including DOXIL®) or 720 mg/m\^2 for epirubicin hydrochloride
* Prior radiotherapy
* Prior intraperitoneal carboplatin or cisplatin as salvage treatment for recurrent ovarian cancer
* Concurrent amifostine or other protective agents
18 Years
120 Years
FEMALE
No
Sponsors
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Ortho Biotech Clinical Affairs, L.L.C.
INDUSTRY
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jayanthi S. Lea, MD
Role: STUDY_CHAIR
Simmons Cancer Center
Locations
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Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Countries
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Other Identifiers
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SCCC-04E07
Identifier Type: -
Identifier Source: secondary_id
SCCC-062007-043
Identifier Type: -
Identifier Source: secondary_id
ORTHO-SCCC-04E07
Identifier Type: -
Identifier Source: secondary_id
CDR0000574034
Identifier Type: -
Identifier Source: org_study_id