Study to Evaluate the Efficacy and Safety of Genexol-PM Once a Week for Gynecologic Cancer

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

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 Overview

• Status: Unknown
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Drug: Genexol-PM

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samyang Biopharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1; Genexol-PM 100mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1	Drug: Genexol-PM; Cremophor EL-free polymeric micelle of paclitaxel
EXPERIMENTAL: Cohort 2; Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1	Drug: Genexol-PM; Cremophor EL-free polymeric micelle of paclitaxel
EXPERIMENTAL: Cohort 3; Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 6 AUC IV infusion D1	Drug: Genexol-PM; Cremophor EL-free polymeric micelle of paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The recommended dose for the phase II study	Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups	2 years
The maximum tolerated dose (MTD)	MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dose limiting toxicity (DLT)	Dose limiting toxicity (DLT) was defined as one of the following cases. NCI CTCAE V3.0 Grade 3 or more hypersensitivity despite premedication, Non-Hematological Toxicity other than nausea and vomiting, Hematological toxicity.	2 years
Toxicities	Clinical/laboratory toxicities were monitored after the treatment, in order to evaluate safety and tolerance of the test drugs, and adverse events, which were maintained until visit on discontinuation date, were followed until recovered or stabilized	2 years

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation
• Investigators: Principal Investigator: Yong Man Kim, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (ESTIMATE): April 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: GPMOC101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO