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

Primary Purpose

Ovarian Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

neoadjuvant chemotherapy (Carboplatin/Docetaxel)

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Ovarian neoplasms,, Neoadjuvant Therapy,, Docetaxel,, Neoplasm, Residual

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Gynaecolgy and Obstetrics, University hopsitalRecruiting
Department of Gynaecology, University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Outcomes

Primary Outcome Measures

Preoperative reduction of ascites volume

Secondary Outcome Measures

Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL

Full Information

NCT ID

NCT00551577

First Posted

October 30, 2007

Last Updated

October 30, 2007

Sponsor

University Hospital, Bonn

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00551577

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Bonn

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Neoplasms

Keywords

Ovarian neoplasms,, Neoadjuvant Therapy,, Docetaxel,, Neoplasm, Residual

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Arm Title

Arm Type

Experimental

Arm Description

2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant chemotherapy (Carboplatin/Docetaxel)

Intervention Description

3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant chemotherapy (Carboplatin/Docetaxel)

Intervention Description

2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Primary Outcome Measure Information:

Title

Preoperative reduction of ascites volume

Time Frame

preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)

Secondary Outcome Measure Information:

Title

Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martin Pölcher, MD

Phone

+49 228 287

Ext

15449

martin.poelcher@ukb.uni-bonn.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walther C Kuhn, Prof. MD

Organizational Affiliation

University of Bonn

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Gynaecolgy and Obstetrics, University hopsital

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Pölcher, MD

Facility Name

Department of Gynaecology, University hospital

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sven Mahner, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20388201

Citation

Polcher M, Rudlowski C, Friedrichs N, Mielich M, Holler T, Wolfgarten M, Kubler K, Buttner 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. doi: 10.1186/1471-2407-10-137.

Results Reference

derived

PubMed Identifier

20087581

Citation

Polcher M, Braun M, Friedrichs N, Rudlowski C, Bercht E, Fimmers R, Sauerwald A, Keyver-Paik MD, Kubler K, Buttner 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. doi: 10.1007/s00262-010-0817-1. Epub 2010 Jan 20.

Results Reference

derived

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

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