Neoadjuvant Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer-Prospective, Randomized Phase II Clinical Trial (PRIMOVAR-1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by University Hospital, Bonn.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00551577
First received: October 30, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Preoperative reduction of ascites volume [ Time Frame: preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course) ]

Secondary Outcome Measures:
  • Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL [ Time Frame: 6 months ]

Estimated Enrollment: 100
Study Start Date: March 2003
Estimated Study Completion Date: January 2008
Arms Assigned Interventions
Active Comparator: A1
3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)
3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
Experimental: A2
2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)
2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551577

Contacts
Contact: Martin Pölcher, MD +49 228 287 ext 15449 martin.poelcher@ukb.uni-bonn.de

Locations
Germany
Department of Gynaecolgy and Obstetrics, University hopsital Recruiting
Bonn, Germany, 53105
Sub-Investigator: Martin Pölcher, MD         
Department of Gynaecology, University hospital Recruiting
Hamburg, Germany, 20246
Sub-Investigator: Sven Mahner, MD         
Sponsors and Collaborators
University Hospital, Bonn
Sanofi
Investigators
Principal Investigator: Walther C Kuhn, Prof. MD University of Bonn
  More Information

No publications provided by University Hospital, Bonn

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00551577     History of Changes
Other Study ID Numbers: PRIMOVAR-1
Study First Received: October 30, 2007
Last Updated: October 30, 2007
Health Authority: Germany: Ethics Commission
Germany: Local health authority of Bonn

Keywords provided by University Hospital, Bonn:
Ovarian neoplasms,
Neoadjuvant Therapy,
Docetaxel,
Neoplasm, Residual

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014