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

October 30, 2007 updated by: University Hospital, Bonn

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Recruiting
        • Department of Gynaecolgy and Obstetrics, University hopsital
        • Sub-Investigator:
          • Martin Pölcher, MD
      • Hamburg, Germany, 20246
        • Recruiting
        • Department of Gynaecology, University hospital
        • Sub-Investigator:
          • Sven Mahner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)
2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 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)
3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preoperative reduction of ascites volume
Time Frame: preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)
preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Collaborators

Sanofi

Investigators

  • Principal Investigator: Walther C Kuhn, Prof. MD, University of Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (ANTICIPATED)

January 1, 2008

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (ESTIMATE)

October 31, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2007

Last Update Submitted That Met QC Criteria

October 30, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIMOVAR-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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