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

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.

Study Overview

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

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: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Level One	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.
Experimental: Dose Level Two	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.
Experimental: Dose Level Three	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 6, 2009
• First Posted (Estimate): April 7, 2009

Study Record Updates

• Last Update Posted (Estimate): June 12, 2012
• Last Update Submitted That Met QC Criteria: June 11, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Antineoplastic Agents; Carboplatin
• Other Study ID Numbers: GPMOC201