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
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC
Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC
Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877253

Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00877253     History of Changes
Other Study ID Numbers: GPMOC201
Study First Received: April 3, 2009
Last Updated: June 11, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014