Clinical trial NCT02739529: Study to Evaluate the Efficacy and Safety of Genexol-PM Once a Week for Gynecologic Cancer
Official title: Dose-dense Paclitaxel (Genexol®-PM) Once a Week in Combination With Carboplatin Every 3 Weeks for Gynecologic Cancer (Adult Solid Tumor): a Phase I Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gynecologic Cancer
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 18
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial.


Eligibility criteria: Inclusion Criteria:

1. Patients who aged 20 years or older and under 80 year old female
2. Patients who were diagnosed histologically or cytologically or who were scheduled to reccur as an gynecologic cancer (epithelial ovarian cancer , fallopian tube cancer, primary peritoneal cancer, cervical cancer, uterine corpus cance, etc)
3. Patients seemed appropriate for Paclitaxel and Carboplatin combination therapy for the treatment
4. Patients whose ECOG performance score are 0-2
5. Patients who have adequate blood, kidney and liver function on screening within 14 days before the administration of the test drugs

   * Hb ≥ 10g/dl: Patients with less than 10g/dl of hemoglobin level were not allowed to use the test drugs unless they were recovered to 10g/dl or more.
   * ANC ≥ 1500/mm3
   * Platelet Count ≥ 100,000/mm3
   * Serum AST and ALT ≤ 2.5 X ULN
   * Serum ALP ≤ 2.5 X ULN
   * Serum creatinine ≤ 2.5 X ULN
6. Patients who participated voluntarily and who provided written informed consent before participating in the study

Exclusion Criteria:

1. Patients with the history of carcinoma in the past 5 years other than gynecologic cancer
2. Patients who received radiotherapy at abdominal cavity or pelvis
3. Patients who were receiving immunotherapy or hormone therapy
4. Patients who received a major surgery other than debulking surgery within 2 weeks before the screening
5. Patients with a past or present medical history of metastasis in central nervous system (CNS)
6. Patients with NCI CTCAE V4.0 Grade 1 or more sensory or motor neuropathy
7. Patients with severe comorbidities as follows

   * medical or mental condition impossible to understand the clinical trial and provide a written informed consent, based on the investigators' decision
   * severe cardiovascular disease (such as ischemic heart disease requiring medical therapy, myocardial infarction within the last 6 months, and grade 2\~4 congestive heart failure defined by New York Heart Association criteria)
   * uncontrolled active infectious disease
   * hypersensitivity to the test drugs or the vehicle
8. Patients who participated in another study within 4 weeks before the screening
9. Pregnant, lactating women or Patients who do not use contraceptive methods that can be medically accepted to the possibility of pregnancy in female volunteers

Primary outcomes:
measure: The maximum tolerated dose (MTD)
timeFrame: 2 years
measure: The recommended dose for the phase II study
timeFrame: 2 years
Secondary outcomes:
measure: The dose limiting toxicity (DLT)
timeFrame: 2 years
measure: Toxicities
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samyang Biopharmaceuticals
Study officials:
affiliation: Asan Medical Center
name: Yong Man Kim
role: PRINCIPAL_INVESTIGATOR
References: