- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00102375
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
Study Overview
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
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Aachen, Germany, 52074
- Gynecologic Hospital of the Medical Facilities RWTH
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Berlin, Germany, 10117
- Clinic for Gynecology and Gyn. Oncology, Humboldt University
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Dresden, Germany, 01307
- University Clinic Carl Gustav Carus, Gynecological hospital
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Duesseldorf, Germany, 40217
- Gynecologic Hospital
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Duesseldorf, Germany, 40225
- University Gynecologic Hospital
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Frankfurt, Germany, 60596
- University Gynecologic Hospital
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Greifswald, Germany, 17487
- Gynecologic Clinic of the Ernst-Moritz-Arndt-University
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Göttingen, Germany, 37075
- University Gynecologic Hospital
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Hannover, Germany, 30659
- Gynecological Clinic of the Medical University
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Karlsruhe, Germany, 76137
- St. Vincentius Gynecologic Hospital
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Kiel, Germany, 24105
- University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
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Magdeburg, Germany, 39108
- Otto-von-Guericke University, University Gynecological Hospital
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Muenchen, Germany, 81377
- University Gynecologic Hospital Grosshadern
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Muenchen, Germany, 81675
- University Gynecologic Hospital "rechts der Isar"
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Muenster, Germany, 48149
- Clinic for Gynecology
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Tuebingen, Germany, 72076
- University Gynecologic Hospital
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Ulm, Germany, 89075
- University Gynecological Hospital
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Wiesbaden, Germany, 65199
- Clinic for Gnyecology and gyn. Oncology HSK
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Survival
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Secondary Outcome Measures
Outcome Measure |
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Response rate
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Progression-free survival
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Quality of Life
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Response duration
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Toxicities
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacobus Pfisterer, Prof. Dr., AGO Study Group
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Topotecan
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.
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