Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer
NCT ID: NCT00886717
Last Updated: 2013-08-02
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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UNKNOWN
PHASE1/PHASE2
74 participants
INTERVENTIONAL
2008-05-31
Brief Summary
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PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.
Detailed Description
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Primary
* Determine the maximum tolerated dose and recommended phase II dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (Phase I)
* Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II)
Secondary
* Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I)
* Evaluate the safety profiles of this regimen in these patients. (Phase I)
* Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II)
* Determine the overall survival of patients treated with this regimen. (Phase II)
* Determine the overall response in patients treated with this regimen. (Phase II)
* Evaluate the safety and toxicity of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter study.
Patients receive paclitaxel-loaded polymeric micelle and carboplatin.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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carboplatin
paclitaxel-loaded polymeric micelle
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed advanced ovarian cancer
* Measurable disease by RECIST criteria
* No prior or concurrent CNS metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 6 months
* Clinically acceptable blood, kidney, and spleen function
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No preexisting sensory or motor neuropathy ≥ grade 1
* No other malignancies within the past 5 years
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for ovarian cancer
* No prior immunotherapy or hormonal therapy for ovarian cancer
* No prior radiotherapy to the pelvis or abdominal cavity
* More than 2 weeks since prior major surgery other than debulking surgery
18 Years
FEMALE
No
Sponsors
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Asan Medical Center
OTHER
Principal Investigators
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Yong Man Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Seoul National University Hospital
Seoul, , South Korea
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center - University of Ulsan College of Medicine
Seoul, , South Korea
Countries
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Facility Contacts
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Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Yong Man Kim, MD, PhD
Role: primary
Other Identifiers
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CDR0000639513
Identifier Type: REGISTRY
Identifier Source: secondary_id
AMC-UUCM-GPMOC201
Identifier Type: -
Identifier Source: org_study_id