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

Phase 1

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC; Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC; Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC

• Registration Number: NCT00877253
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Level One	Genexol-PM 220mg/㎡, Carboplatin 5AUC	-
Dose Level Two	Genexol-PM 260mg/㎡, Carboplatin 5AUC	-
Dose Level Three	Genexol-PM 300mg/㎡, Carboplatin 5AUC	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)