Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

August 3, 2006 updated by: AGO Study Group

Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan

The purpose of this study is to determine whether the triple combination of Carboplatin, Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of Carboplatin and Paclitaxel.

Study Overview

Status

Completed

Conditions

Ovarian Cancer

Intervention / Treatment

Drug: Topotecan

Detailed Description

Carboplatin-Paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer. One option to further improve the therapeutic results is the incorporation of a third, non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer. In two separate, single center phase II studies, a different combination of the three active agents (Carboplatin, Paclitaxel and Topotecan) has been tested. In these studies, Carboplatin and Paclitaxel were given at standard doses and schedules, followed sequentially by Topotecan which was well tolerated at a dose of 1.25 mg/m2/day given for five days and repeated every 21 days. The prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good.

Study Hypothesis/Comparison: The triple combination (Carboplatin/Paclitaxel/Topotecan) yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin + Paclitaxel

Study Type

Interventional

Enrollment

900

Phase

Phase 3

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
- - Aachen, Germany, 52074
    - Gynecologic Hospital of the Medical Facilities RWTH
  - Berlin, Germany, 10117
    - Clinic for Gynecology and Gyn. Oncology, Humboldt University
  - Dresden, Germany, 01307
    - University Clinic Carl Gustav Carus, Gynecological hospital
  - Duesseldorf, Germany, 40217
    - Gynecologic Hospital
  - Duesseldorf, Germany, 40225
    - University Gynecologic Hospital
  - Frankfurt, Germany, 60596
    - University Gynecologic Hospital
  - Greifswald, Germany, 17487
    - Gynecologic Clinic of the Ernst-Moritz-Arndt-University
  - Göttingen, Germany, 37075
    - University Gynecologic Hospital
  - Hannover, Germany, 30659
    - Gynecological Clinic of the Medical University
  - Karlsruhe, Germany, 76137
    - St. Vincentius Gynecologic Hospital
  - Kiel, Germany, 24105
    - University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
  - Magdeburg, Germany, 39108
    - Otto-von-Guericke University, University Gynecological Hospital
  - Muenchen, Germany, 81377
    - University Gynecologic Hospital Grosshadern
  - Muenchen, Germany, 81675
    - University Gynecologic Hospital "rechts der Isar"
  - Muenster, Germany, 48149
    - Clinic for Gynecology
  - Tuebingen, Germany, 72076
    - University Gynecologic Hospital
  - Ulm, Germany, 89075
    - University Gynecological Hospital
  - Wiesbaden, Germany, 65199
    - Clinic for Gnyecology and gyn. Oncology HSK

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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Histologically proven epithelial carcinoma of the ovary or of the fallopian tube or extraovarian papillary serous carcinoma with extent to the ovary
International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IV, regardless of measurable or non-measurable disease
No prior chemo- or radiotherapy
Adequate hematologic, renal and hepatic function:
- ANC ≥ 1.5 x 10^9/L,
- Platelet counts ≥ 100 x 10^9/L,
- Total bilirubin ≤ 1.5 x upper normal limit,
- Alkaline Phosphatase ≤ 3 x upper normal limit,
- Serum creatinine ≤ 1.25 upper normal limit,
- Estimated GFR ≥ 60 ml/min
Performance status 0-2 (ECOG)
Life expectancy must be greater than 12 weeks

Exclusion Criteria:

Non-epithelial tumors or mixed epithelial/non-epithelial tumors (e.g. mixed Mullerian tumors) or tumors of low malignant potential (borderline tumors)
Prior treatment with chemo- or radiotherapy
Administration of other simultaneous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy
History of congestive heart failure
Symptomatic brain metastasis
Complete bowel obstruction
Dementia
Active infection or other serious underlying medical condition
Pre-existing motor or sensory neurologic pathology

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: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
Response rate
Progression-free survival
Quality of Life
Response duration
Toxicities

Collaborators and Investigators

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

Sponsor

AGO Study Group

Investigators

Principal Investigator: Jacobus Pfisterer, Prof. Dr., AGO Study Group

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

Pfisterer J, Weber B, Reuss A, Kimmig R, du Bois A, Wagner U, Bourgeois H, Meier W, Costa S, Blohmer JU, Lortholary A, Olbricht S, Stahle A, Jackisch C, Hardy-Bessard AC, Mobus V, Quaas J, Richter B, Schroder W, Geay JF, Luck HJ, Kuhn W, Meden H, Nitz U, Pujade-Lauraine E; AGO-OVAR; GINECO. Randomized phase III trial of topotecan following carboplatin and paclitaxel in first-line treatment of advanced ovarian cancer: a gynecologic cancer intergroup trial of the AGO-OVAR and GINECO. J Natl Cancer Inst. 2006 Aug 2;98(15):1036-45. doi: 10.1093/jnci/djj296.

Helpful Links

Information on studies of the AGO-OVAR on Ovarian cancer

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

December 1, 1999

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

January 29, 2005

First Submitted That Met QC Criteria

January 28, 2005

First Posted (Estimate)

January 31, 2005

Study Record Updates

Last Update Posted (Estimate)

August 4, 2006

Last Update Submitted That Met QC Criteria

August 3, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AGO-OVAR 7

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.