Trial record 16 of 1849 for: Ovarian Cancer: Clinical Trials

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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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Docetaxel

U.S. FDA Resources

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

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 Hospital, Bonn

More Information

No publications provided by University Hospital, Bonn

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pölcher M, Rudlowski C, Friedrichs N, Mielich M, Höller T, Wolfgarten M, Kübler K, Büttner R, Kuhn W, Braun M. In vivo intratumor angiogenic treatment effects during taxane-based neoadjuvant chemotherapy of ovarian cancer. BMC Cancer. 2010 Apr 13;10:137.

Pölcher M, Braun M, Friedrichs N, Rudlowski C, Bercht E, Fimmers R, Sauerwald A, Keyver-Paik MD, Kübler K, Büttner R, Kuhn WC, Hernando JJ. Foxp3(+) cell infiltration and granzyme B(+)/Foxp3(+) cell ratio are associated with outcome in neoadjuvant chemotherapy-treated ovarian carcinoma. Cancer Immunol Immunother. 2010 Jun;59(6):909-19. Epub 2010 Jan 20.

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 May 23, 2013

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