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

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ClinicalTrials.gov Identifier: NCT00886717
Recruitment Status : Unknown
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 23, 2009
Last Update Posted : August 2, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: carboplatin Drug: paclitaxel-loaded polymeric micelle Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Non-Randomized
Masking: None (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
Study Start Date : May 2008





Primary Outcome Measures :
  1. Maximum tolerated dose and recommended phase II dose (Phase I)
  2. Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II)

Secondary Outcome Measures :
  1. Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I)
  2. Safety profiles (Phase I)
  3. Objective response rate as measured by RECIST criteria (Phase II)
  4. Overall survival (Phase II)
  5. Overall response (Phase II)
  6. Safety and toxicity (Phase II)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886717


Locations
Korea, Republic of
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      
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Contact Person    82-2-3410-0200      
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      
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Yong Man Kim, MD, PhD Asan Medical Center

ClinicalTrials.gov Identifier: NCT00886717     History of Changes
Other Study ID Numbers: AMC-UUCM-GPMOC201
CDR0000639513 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: December 2009

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
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action