Neoadjuvant Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer-Prospective, Randomized Phase II Clinical Trial

Ovarian Neoplasms Clinical Trial

— PRIMOVAR-1  

Official title:

Prospective, Randomized Phase II Clinical Trial to Select Primary Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer Stage FIGO IIIC and IV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00551577
• Other study ID #: PRIMOVAR-1
• Status: Recruiting
• Phase: Phase 2
• First received: October 30, 2007
• Last updated: October 30, 2007
• Start date: March 2003
• Est. completion date: January 2008

Study information

• Verified date: October 2007
• Source: University Hospital, Bonn
• Contact: Martin Pölcher, MD
• Phone: +49 228 287
• Email: martin.poelcher[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Local health authority of Bonn
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Procedure:
• neoadjuvant chemotherapy (Carboplatin/Docetaxel)
3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
• neoadjuvant chemotherapy (Carboplatin/Docetaxel)
2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Locations

Country	Name	City	State
Germany	Department of Gynaecolgy and Obstetrics, University hopsital	Bonn
Germany	Department of Gynaecology, University hospital	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative reduction of ascites volume		preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)
Secondary	Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL		6 months