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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


Phase 1
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer.

Outcome Time Frame:

until either MTD is achieved or maximum planned dose is tested

Safety Issue:

Yes

Principal Investigator

Soon Beom Kang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

GPMOC201

NCT ID:

NCT00877253

Start Date:

May 2008

Completion Date:

June 2009

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms

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