Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
AGO Study Group
ClinicalTrials.gov Identifier:
NCT00102375
First received: January 29, 2005
Last updated: August 3, 2006
Last verified: February 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

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

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

ClinicalTrials.gov processed this record on September 16, 2014