Status:
COMPLETED
Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer
Lead Sponsor:
Samyang Biopharmaceuticals Corporation
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advan...
Detailed Description
This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the efficacy and safety of Gen...
Eligibility Criteria
Inclusion
- Women ≥ 18 years old.
- Signed informed consent before inclusion.
- Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV)
- Subjects who have measurable disease by RECIST after debulking surgery.
- ECOG performance status of 0, 1, or 2.
- Estimated life expectancy of more than 6 months
- Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit
- Hb ≥ 10g/dl
- ANC ≥ 1.5×10\^9/L
- Platelet Count ≥ 100×10\^9/L
- Serum total bilirubin ≤ 1.5×ULN
- Serum AST and ALT ≤ 2.5×ULN
- Serum ALP ≤ 2.5×ULN
- Serum creatinine ≤ 1.5×ULN
Exclusion
- Subjects who have received chemotherapy for ovarian cancer other than debulking surgery.
- Subjects who have a history of radiotherapy to pelvis or abdominal cavity
- Subjects who receive immunotherapy or hormonal therapy for ovarian cancer
- Subjects who have other malignancies within the past 5 years
- Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit
- Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS)
- Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on NCI CTCAE V3.0
- Subjects who have serious medical condition
- Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure)
- Uncontrollable infection
- Previous allergic reactions in connection with paclitaxel and carboplatin
- Subjects who participate another clinical trial within the last 4 weeks before inclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00877253
Start Date
May 1 2008
End Date
June 1 2009
Last Update
June 12 2012
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