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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00886717
First received: April 22, 2009
Last updated: August 1, 2013
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: carboplatin
Drug: paclitaxel-loaded polymeric micelle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose and recommended phase II dose (Phase I) [ Designated as safety issue: Yes ]
  • Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II) [ Designated as safety issue: No ]

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) [ Designated as safety issue: No ]
  • Safety profiles (Phase I) [ Designated as safety issue: Yes ]
  • Objective response rate as measured by RECIST criteria (Phase II) [ Designated as safety issue: No ]
  • Overall survival (Phase II) [ Designated as safety issue: No ]
  • Overall response (Phase II) [ Designated as safety issue: No ]
  • Safety and toxicity (Phase II) [ Designated as safety issue: Yes ]

Estimated Enrollment: 74
Study Start Date: May 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886717

Locations
Korea, Republic of
Asan Medical Center - University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Yong Man Kim, MD, PhD    82-2-3010-3640      
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Contact Person    82-2-3410-0200      
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Contact Person    82-2-763-5110      
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Contact Person    82-2-392-5594      
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Yong Man Kim, MD, PhD Asan Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00886717     History of Changes
Other Study ID Numbers: AMC-UUCM-GPMOC201, CDR0000639513
Study First Received: April 22, 2009
Last Updated: August 1, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014