NCT00886717

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_1 ovarian-cancer

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
Last Updated

August 2, 2013

Status Verified

December 1, 2009

First QC Date

April 22, 2009

Last Update Submit

August 1, 2013

Conditions

Ovarian Cancer

Keywords

stage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancerstage IV ovarian epithelial cancerstage IIIA ovarian germ cell tumorstage IIIB ovarian germ cell tumorstage IIIC ovarian germ cell tumorstage IV ovarian germ cell tumor

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Interventions

carboplatinDRUG
paclitaxel-loaded polymeric micelleDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Asan Medical Center - University of Ulsan College of Medicine

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Carboplatingenexol-PM

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Yong Man Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

May 1, 2008

Last Updated

August 2, 2013

Record last verified: 2009-12

Locations

KR(4)