NCT00170664

Brief Summary

The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I study now a multi-center phase II-trial was conducted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P75+ for phase_2 ovarian-cancer

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 1999

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

4.2 years

First QC Date

September 12, 2005

Last Update Submit

March 24, 2016

Conditions

Ovarian Cancer

Keywords

Ovarian neoplasmspaclitaxel, carboplatinclinical trials, phase IIfirst-line chemotherapyweekly therapy schedule

Study Arms (1)

Paclitaxel, Carboplatin

EXPERIMENTAL
Drug: PaclitaxelDrug: Carboplatin

Interventions

PaclitaxelDRUG
Paclitaxel, Carboplatin
CarboplatinDRUG
Paclitaxel, Carboplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically-confirmed epithelial ovarian cancer of FIGO stage IIB - IV
  • life expectancy of more than three months
  • ECOG performance status less than 3
  • laboratory parameters within the normal range, including a glomerular filtration rate (GFR) greater than 60 ml/min, serum creatinine levels below 1.6 mg/dl, liver transaminases less than two times the normal levels, bilirubin concentrations below 1.5 mg/dl, adequate bone marrow function as indicated by a neutrophil count greater than 1,500/µl, and a platelet count greater than 100,000/µl.
  • written informed consent

You may not qualify if:

  • suffering from secondary malignancy or underlying serious, uncontrolled concurrent medical or psychiatric disease
  • radiotherapy within 4 weeks for study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Campus Virchow-Klinikum

Berlin, 13533, Germany

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

  • Werner Lichtenegger

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

January 1, 1999

Primary Completion

March 1, 2003

Study Completion

September 1, 2004

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

DE(1)