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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877253
• Other study ID #: GPMOC201
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2009
• Last updated: June 11, 2012
• Start date: May 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2012
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Objective Response Rate (Complete Response (CR) + Partial Response (PR))		about 1 year (until end of trial)	Yes
Secondary	Time to Tumor Progression		about 1 year (until end of trial)	Yes
Secondary	Overall Survival		about 1 year (until end of trial)	Yes
Secondary	Safety profiles		about 1 year (till end of trial)	Yes