NCT00919984

Brief Summary

Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer. Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy. Recently, intraperitoneal combination chemotherapy has been reported to be effective in ovarian cancer. We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel + carboplatin plus intraperitoneal paclitaxel chemotherapy.

Trial Health

57
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Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

3.4 years

First QC Date

June 7, 2009

Last Update Submit

May 7, 2014

Conditions

Ovarian Neoplasms

Keywords

OVARIAN NEOPLASMSADJUVANT CHEMOTHERAPYINTRAPERITONEAL CHEMOTHERAPY

Outcome Measures

Primary Outcomes (1)

  • 2 year progression-free survival rate.

    The time from randomization to the time of disease progression as determined by the investigator or death from any cause. Progression is diagnosed by imaging or serial tumor marker elevation.

    2 Year after initial surgery

Secondary Outcomes (3)

  • Median overall survival

    From entry into the study to 5 year after treatment or until half of participants are dead

  • 5 year progression-free survival rate

    5 year after initial surgery

  • 5 year overall survival rate

    5 year after initial surgery

Study Arms (1)

IP Chemotherapy

EXPERIMENTAL

Patients with optimally debulked advanced (stage 3 or 4) epithelial ovarian cancer; IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles

Drug: IP chemotherapy

Interventions

IP chemotherapyDRUG

IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles

Also known as: Paclitaxel, Carboplatin
IP Chemotherapy

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>=20 and \<=75
  • Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, tubal cancer
  • Stage 3 or 4
  • WBC \>= 3500/mm3, ANC \>= 1500/mm3, platelet \>= 100000/mm3, hemoglobin \>= 10 g/dl
  • Serum creatinine \<= upper normal limit \* 1.25
  • Total bilirubin \<= 1.5mg/mm3, ALT/AST \<= upper normal limit \* 3, ALP \<= upper normal limit \* 3
  • Adequate compliance and geographical closeness which make adequate follow-up possible
  • GOG performance status 0-2
  • Anticipated survival \>= 3 months
  • Who agreed to participate in this study and signed on informed consent form

You may not qualify if:

  • History of chemotherapy or radiotherapy on abdomen/pelvis area
  • Pleural/pericardial effusion, ascites causing respiratory difficulties \>= NCI-CTCAE grade 2
  • History of other cancers within 5 years
  • History of unapproved therapy within 30 days before enrollment
  • Other serious diseases which could threat the safety of participants or impair the ability of participants to complete the participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences

Seoul, 139-706, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

PaclitaxelCarboplatin

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 Disorders

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • SANG YOUNG RYU, M.D.

    KOREA CANCER CENTER HOSPITAL, KOREA INSTITUTE OF RADIOLOGICAL & MEDICAL SCIENCES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Cerivcal/Ovarian Cancer Center

Study Record Dates

First Submitted

June 7, 2009

First Posted

June 12, 2009

Study Start

May 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations

KR(1)