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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00170664
Enrollment
129
Registered
2005-09-15
Start date
1999-01-31
Completion date
2004-09-30
Last updated
2016-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

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

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.

Interventions

DRUGPaclitaxel
DRUGCarboplatin

Sponsors

North Eastern German Society of Gynaecological Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026