Trial | NCT00877253  Report issue

Title

Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer
Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    paclitaxel carboplatin ...

  • Study Participants

    18
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.
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.
Study Started
May 31
2008
Primary Completion
Jun 30
2009
Study Completion
Jun 30
2009
Last Update
Jun 12
2012
Estimate

Drug Genexol-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.

Drug Genexol-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.

Drug Genexol-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.

Dose Level One Experimental

Dose Level Two Experimental

Dose Level Three Experimental

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
No Results Posted