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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Samyang Biopharmaceuticals Corporation

ClinicalTrials.gov Identifier:

NCT00877253

First received: April 3, 2009

Last updated: June 11, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 3, 2009

Last Updated Date

June 11, 2012

Start Date ^ICMJE

May 2008

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer. [ Time Frame: until either MTD is achieved or maximum planned dose is tested ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and carboplatin. [ Time Frame: until either MTD is achieved or maximum planned dose is tested ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00877253 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Objective Response Rate (Complete Response (CR) + Partial Response (PR)) [ Time Frame: about 1 year (until end of trial) ] [ Designated as safety issue: Yes ]
Time to Tumor Progression [ Time Frame: about 1 year (until end of trial) ] [ Designated as safety issue: Yes ]
Overall Survival [ Time Frame: about 1 year (until end of trial) ] [ Designated as safety issue: Yes ]
Safety profiles [ Time Frame: about 1 year (till end of trial) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Dose Level One
Intervention: Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC
Experimental: Dose Level Two
Intervention: Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC
Experimental: Dose Level Three
Intervention: Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00877253

Other Study ID Numbers ^ICMJE

GPMOC201

Has Data Monitoring Committee

Responsible Party

Samyang Biopharmaceuticals Corporation

Study Sponsor ^ICMJE

Samyang Biopharmaceuticals Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Soon Beom Kang, MD, PhD	Seoul National University Hospital
Principal Investigator:	Yong Man Kim, MD, PhD	Asan Medical Center
Principal Investigator:	Byoung Gie Kim, MD, PhD	Samsung Medical Center
Principal Investigator:	Young Tae Kim, MD, PhD	Yonsei University Health System Severance Hospital

Information Provided By

Samyang Biopharmaceuticals Corporation

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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