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Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
carboplatin
paclitaxel-loaded polymeric micelle
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor, stage IV ovarian germ cell tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced ovarian cancer
  • Measurable disease by RECIST criteria
  • No prior or concurrent CNS metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 6 months
  • Clinically acceptable blood, kidney, and spleen function
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No preexisting sensory or motor neuropathy ≥ grade 1
  • No other malignancies within the past 5 years

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for ovarian cancer
  • No prior immunotherapy or hormonal therapy for ovarian cancer
  • No prior radiotherapy to the pelvis or abdominal cavity
  • More than 2 weeks since prior major surgery other than debulking surgery

Sites / Locations

  • Seoul National University HospitalRecruiting
  • Yonsei Cancer Center at Yonsei University Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Asan Medical Center - University of Ulsan College of MedicineRecruiting

Outcomes

Primary Outcome Measures

Maximum tolerated dose and recommended phase II dose (Phase I)
Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II)

Secondary Outcome Measures

Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I)
Safety profiles (Phase I)
Objective response rate as measured by RECIST criteria (Phase II)
Overall survival (Phase II)
Overall response (Phase II)
Safety and toxicity (Phase II)

Full Information

First Posted
April 22, 2009
Last Updated
August 1, 2013
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00886717
Brief Title
Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer
Official Title
Open-label, Multicenter, Phase I/II Trial to Evaluate Efficacy Safety of the Combination Therapy of Genexol-PM and Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Asan Medical Center

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.
Detailed Description
OBJECTIVES: Primary Determine the maximum tolerated dose and recommended phase II dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (Phase I) Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II) Secondary Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I) Evaluate the safety profiles of this regimen in these patients. (Phase I) Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II) Determine the overall survival of patients treated with this regimen. (Phase II) Determine the overall response in patients treated with this regimen. (Phase II) Evaluate the safety and toxicity of this regimen in these patients. (Phase II) OUTLINE: This is a multicenter study. Patients receive paclitaxel-loaded polymeric micelle and carboplatin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor, stage IV ovarian germ cell tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel-loaded polymeric micelle
Primary Outcome Measure Information:
Title
Maximum tolerated dose and recommended phase II dose (Phase I)
Title
Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II)
Secondary Outcome Measure Information:
Title
Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I)
Title
Safety profiles (Phase I)
Title
Objective response rate as measured by RECIST criteria (Phase II)
Title
Overall survival (Phase II)
Title
Overall response (Phase II)
Title
Safety and toxicity (Phase II)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced ovarian cancer Measurable disease by RECIST criteria No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 6 months Clinically acceptable blood, kidney, and spleen function Not pregnant or nursing Fertile patients must use effective contraception No preexisting sensory or motor neuropathy ≥ grade 1 No other malignancies within the past 5 years PRIOR CONCURRENT THERAPY: No prior chemotherapy for ovarian cancer No prior immunotherapy or hormonal therapy for ovarian cancer No prior radiotherapy to the pelvis or abdominal cavity More than 2 weeks since prior major surgery other than debulking surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Man Kim, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
82-2-763-5110
Facility Name
Yonsei Cancer Center at Yonsei University Medical Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
82-2-392-5594
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
82-2-3410-0200
Facility Name
Asan Medical Center - University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Man Kim, MD, PhD
Phone
82-2-3010-3640

12. IPD Sharing Statement

Learn more about this trial

Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer

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