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Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
This study has been completed.
First Received: January 29, 2005   Last Updated: August 3, 2006   History of Changes
Sponsored by: AGO Ovarian Cancer Study Group
Information provided by: AGO Ovarian Cancer Study Group
ClinicalTrials.gov Identifier: NCT00102375
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: Topotecan
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AGO Ovarian Cancer Study Group:

Primary Outcome Measures:
  • Survival

Secondary Outcome Measures:
  • Progression-free survival
  • Response rate
  • Response duration
  • Toxicities
  • Quality of Life

Estimated Enrollment: 900
Study Start Date: December 1999
Estimated Study Completion Date: October 2004
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102375

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

Additional Information:
Publications:
Study ID Numbers: AGO-OVAR 7
Study First Received: January 29, 2005
Last Updated: August 3, 2006
ClinicalTrials.gov Identifier: NCT00102375     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AGO Ovarian Cancer Study Group:
Ovarian Cancer
first-line
Topotecan

Study placed in the following topic categories:
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Carboplatin
Ovarian Diseases
Ovarian Epithelial Cancer
Carcinoma
Genital Diseases, Female
Paclitaxel
Tubulin Modulators
Ovarian Cancer
Endocrinopathy
Topotecan
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Carboplatin
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Topotecan
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009