Overview

Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
Female
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 advanced ovarian cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samyang Biopharmaceuticals Corporation
Treatments:
Carboplatin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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