NCT00877253

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
Completed

Started May 2008

Shorter than P25 for phase_1 ovarian-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

1.1 years

First QC Date

April 3, 2009

Last Update Submit

June 11, 2012

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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)

Study Arms (3)

Dose Level One

EXPERIMENTAL
Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC

Dose Level Two

EXPERIMENTAL
Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC

Dose Level Three

EXPERIMENTAL
Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC

Interventions

Genexol-PM 220mg/㎡, Carboplatin 5AUCDRUG

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.

Dose Level One
Genexol-PM 260mg/㎡, Carboplatin 5AUCDRUG

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.

Dose Level Two
Genexol-PM 300mg/㎡, Carboplatin 5AUCDRUG

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.

Dose Level Three

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women ≥ 18 years old.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

genexol-PM

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 7, 2009

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 12, 2012

Record last verified: 2012-06