Clinical trial NCT00877253: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Cancer
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer.
timeFrame: until either MTD is achieved or maximum planned dose is tested
Secondary outcomes:
measure: Objective Response Rate (Complete Response (CR) + Partial Response (PR))
timeFrame: about 1 year (until end of trial)
measure: Time to Tumor Progression
timeFrame: about 1 year (until end of trial)
measure: Overall Survival
timeFrame: about 1 year (until end of trial)
measure: Safety profiles
timeFrame: about 1 year (till end of trial)
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Soon Beom Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Yong Man Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Byoung Gie Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yonsei University Health System Severance Hospital
name: Young Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: