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

Sponsors and Collaborators:	University Hospital, Bonn Sanofi-Aventis
Information provided by:	University Hospital, Bonn
ClinicalTrials.gov Identifier:	NCT00551577

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 II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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
A1: Active Comparator 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
A2: Experimental 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

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-Aventis

Investigators

Principal Investigator:

Walther C Kuhn, Prof. MD

University Hospital, Bonn

More Information

Study ID Numbers:	PRIMOVAR-1
Study First Received:	October 30, 2007
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00551577
Health Authority:	Germany: Ethics Commission; Germany: Local health authority of Bonn

Keywords provided by University Hospital, Bonn:

Ovarian neoplasms,
Neoadjuvant Therapy,
Docetaxel,
Neoplasm, Residual

Study placed in the following topic categories:

Neoplasm, Residual
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms

Ovarian Diseases
Carboplatin
Genital Diseases, Female
Docetaxel
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009