Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer
Conditions
Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: 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
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: carboplatin Type: Drug
Name: paclitaxel-loaded polymeric micelle Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Locations
Asan Medical Center - University of Ulsan College of Medicine
Seoul, Korea, Republic of
Status: Recruiting
Contact: Yong Man Kim, MD, PhD - 82-2-3010-3640
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Contact Person - 82-2-3410-0200
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Contact Person - 82-2-763-5110
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Contact Person - 82-2-392-5594
Start Date
May 2008
Sponsors
Asan Medical Center
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page