Neoadjuvant Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer-Prospective, Randomized Phase II Clinical Trial
Conditions
Ovarian Neoplasms
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
Ovarian neoplasms,, Neoadjuvant Therapy,, Docetaxel,, Neoplasm, Residual
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: neoadjuvant chemotherapy (Carboplatin/Docetaxel) Type: Procedure
Name: neoadjuvant chemotherapy (Carboplatin/Docetaxel) Type: Procedure
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and observation of anatomical and biological indicators (i.e. ascites or continuous measurement of tumor marker CA 125). Furthermore the optimal number of preoperative administered cycles of combination chemotherapy with carboplatin and docetaxel should be determined.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- histological confirmed ovarian neoplasm

- Figo stage IIIC (2cm extrapelvic disease) or Figo IV

- more than 500 ml ascites volume (measured by sonography)

- age > 18 years old

- ECOG <= 2

- adequate hepatological, renal and haematological function

- informed consent

Exclusion Criteria:

- concomitant or previous malignant diseases

- debulking procedures on initial surgical approach

- existing peripheral sensoric neuropathy >= grade 2

- acute infections

- mental disorders, cerebral metastasis

- bowel obstruction
Locations
Department of Gynaecolgy and Obstetrics, University hopsital
Bonn, Germany
Status: Recruiting
Department of Gynaecology, University hospital
Hamburg, Germany
Status: Recruiting
Start Date
March 2003
Completion Date
January 2008
Sponsors
University Hospital, Bonn
Source
University Hospital, Bonn
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page