Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
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
1 other identifier
interventional
900
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 ovarian-cancer
Started Dec 1999
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 29, 2005
CompletedFirst Posted
Study publicly available on registry
January 31, 2005
CompletedAugust 4, 2006
February 1, 2006
January 29, 2005
August 3, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
Secondary Outcomes (5)
Progression-free survival
Response rate
Response duration
Toxicities
Quality of Life
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AGO Study Grouplead
Study Sites (18)
Gynecologic Hospital of the Medical Facilities RWTH
Aachen, 52074, Germany
Clinic for Gynecology and Gyn. Oncology, Humboldt University
Berlin, 10117, Germany
University Clinic Carl Gustav Carus, Gynecological hospital
Dresden, 01307, Germany
Gynecologic Hospital
Düsseldorf, 40217, Germany
University Gynecologic Hospital
Düsseldorf, 40225, Germany
University Gynecologic Hospital
Frankfurt, 60596, Germany
University Gynecologic Hospital
Göttingen, 37075, Germany
Gynecologic Clinic of the Ernst-Moritz-Arndt-University
Greifswald, 17487, Germany
Gynecological Clinic of the Medical University
Hanover, 30659, Germany
St. Vincentius Gynecologic Hospital
Karlsruhe, 76137, Germany
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
Kiel, 24105, Germany
Otto-von-Guericke University, University Gynecological Hospital
Magdeburg, 39108, Germany
University Gynecologic Hospital Grosshadern
München, 81377, Germany
University Gynecologic Hospital "rechts der Isar"
München, 81675, Germany
Clinic for Gynecology
Münster, 48149, Germany
University Gynecologic Hospital
Tübingen, 72076, Germany
University Gynecological Hospital
Ulm, 89075, Germany
Clinic for Gnyecology and gyn. Oncology HSK
Wiesbaden, 65199, Germany
Related Publications (1)
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.
PMID: 16882940RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacobus Pfisterer, Prof. Dr.
AGO Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 29, 2005
First Posted
January 31, 2005
Study Start
December 1, 1999
Study Completion
October 1, 2004
Last Updated
August 4, 2006
Record last verified: 2006-02