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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Genexol-PM 220mg/㎡, Carboplatin 5AUC
Genexol-PM 260mg/㎡, Carboplatin 5AUC
Genexol-PM 300mg/㎡, Carboplatin 5AUC
Sponsored by
Samyang Biopharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Dose Level One

    Dose Level Two

    Dose Level Three

    Arm Description

    Outcomes

    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.

    Secondary Outcome Measures

    Objective Response Rate (Complete Response (CR) + Partial Response (PR))
    Time to Tumor Progression
    Overall Survival
    Safety profiles

    Full Information

    First Posted
    April 3, 2009
    Last Updated
    June 11, 2012
    Sponsor
    Samyang Biopharmaceuticals Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00877253
    Brief Title
    Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Samyang Biopharmaceuticals Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dose Level One
    Arm Type
    Experimental
    Arm Title
    Dose Level Two
    Arm Type
    Experimental
    Arm Title
    Dose Level Three
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Genexol-PM 220mg/㎡, Carboplatin 5AUC
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Genexol-PM 260mg/㎡, Carboplatin 5AUC
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Genexol-PM 300mg/㎡, Carboplatin 5AUC
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate (Complete Response (CR) + Partial Response (PR))
    Time Frame
    about 1 year (until end of trial)
    Title
    Time to Tumor Progression
    Time Frame
    about 1 year (until end of trial)
    Title
    Overall Survival
    Time Frame
    about 1 year (until end of trial)
    Title
    Safety profiles
    Time Frame
    about 1 year (till end of trial)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Soon Beom Kang, MD, PhD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yong Man Kim, MD, PhD
    Organizational Affiliation
    Asan Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Byoung Gie Kim, MD, PhD
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Young Tae Kim, MD, PhD
    Organizational Affiliation
    Yonsei University Health System Severance Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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