Ovarian Cancer
Conditions
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 advanced ovarian cancer.
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 Genexol®-PM when administered with Carboplatin in subjects with advanced ovarian cancer after debulking surgery.
Interventions
DRUGGenexol-PM 220mg/㎡, Carboplatin 5AUC
Genexol-PM 220mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
DRUGGenexol-PM 260mg/㎡, Carboplatin 5AUC
Genexol-PM 260mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
DRUGGenexol-PM 300mg/㎡, Carboplatin 5AUC
Genexol-PM 300mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer. | until either MTD is achieved or maximum planned dose is tested |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (Complete Response (CR) + Partial Response (PR)) | about 1 year (until end of trial) |
| Time to Tumor Progression | about 1 year (until end of trial) |
| Overall Survival | about 1 year (until end of trial) |
| Safety profiles | about 1 year (till end of trial) |
Outcome results
None listed