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CompletedNCT00170664Updated Mar 25, 2016

Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer

A Phase 2 interventional study of Paclitaxel and Carboplatin in Ovarian Cancer, sponsored by North Eastern German Society of Gynaecological Oncology. Completed at 1 site in Germany. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-25.

Sponsored by North Eastern German Society of Gynaecological Oncology · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
129
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Ovarian Cancer

Keywords

  • Ovarian neoplasms
  • paclitaxel, carboplatin
  • clinical trials, phase II
  • first-line chemotherapy
  • weekly therapy schedule
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 129 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

North Eastern German Society of Gynaecological Oncology is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • suffering from secondary malignancy or underlying serious, uncontrolled concurrent medical or psychiatric disease
  • radiotherapy within 4 weeks for study entry
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
129 participants (actual)

Study arms

  • Experimental
    Paclitaxel, Carboplatin

    Drug: Paclitaxel · Drug: Carboplatin

Interventions

  • DrugPaclitaxel
  • DrugCarboplatin
06

Study locations

1 site
  • Charité Campus Virchow-Klinikum
    Berlin, 13533, Germany
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00170664
Lead sponsor
North Eastern German Society of Gynaecological Oncology
First posted
Sep 15, 2005
Start date
Jan 1999
Primary completion
Mar 2003
Completion
Sep 2004
Last update
Mar 25, 2016

Study contacts

Werner Lichtenegger
principal investigator · Charite University, Berlin, Germany
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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