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

NCT ID: NCT00877253

Last Updated: 2012-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-06-30

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Level One

Group Type: EXPERIMENTAL

Genexol-PM 220mg/㎡, Carboplatin 5AUC

Intervention Type: DRUG

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.

Dose Level Two

Group Type: EXPERIMENTAL

Genexol-PM 260mg/㎡, Carboplatin 5AUC

Intervention Type: DRUG

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.

Dose Level Three

Group Type: EXPERIMENTAL

Genexol-PM 300mg/㎡, Carboplatin 5AUC

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soon Beom Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Yong Man Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Byoung Gie Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Young Tae Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health System Severance Hospital

Other Identifiers

GPMOC201

Identifier Type: -

Identifier Source: org_study_id