Status:
UNKNOWN
Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping...
Detailed Description
OBJECTIVES: 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 ovaria...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00886717
Start Date
May 1 2008
Last Update
August 2 2013
Active Locations (4)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744
2
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea, 120-752
3
Samsung Medical Center
Seoul, South Korea, 135-710
4
Asan Medical Center - University of Ulsan College of Medicine
Seoul, South Korea, 138-736