Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

Last updated: August 3, 2006
Sponsor: AGO Study Group
Overall Status: Completed

Phase

3

Condition

Ovarian Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT00102375
AGO-OVAR 7
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven epithelial carcinoma of the ovary or of the fallopian tube orextraovarian papillary serous carcinoma with extent to the ovary

  • International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IV, regardlessof 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

Exclusion Criteria:

  • Non-epithelial tumors or mixed epithelial/non-epithelial tumors (e.g. mixed Mulleriantumors) or tumors of low malignant potential (borderline tumors)

  • Prior treatment with chemo- or radiotherapy

  • Administration of other simultaneous chemotherapeutic drugs or hormonal therapy orsimultaneous radiotherapy during the study treatment period or planned whole abdominalradiotherapy

  • 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 Design

Total Participants: 900
Study Start date:
December 01, 1999
Estimated Completion Date:
October 31, 2004

Study 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

Connect with a study center

  • Gynecologic Hospital of the Medical Facilities RWTH

    Aachen, 52074
    Germany

    Site Not Available

  • Clinic for Gynecology and Gyn. Oncology, Humboldt University

    Berlin, 10117
    Germany

    Site Not Available

  • University Clinic Carl Gustav Carus, Gynecological hospital

    Dresden, 01307
    Germany

    Site Not Available

  • Gynecologic Hospital

    Duesseldorf, 40217
    Germany

    Site Not Available

  • University Gynecologic Hospital

    Duesseldorf, 40225
    Germany

    Site Not Available

  • University Gynecologic Hospital

    Frankfurt, 60596
    Germany

    Site Not Available

  • Gynecologic Clinic of the Ernst-Moritz-Arndt-University

    Greifswald, 17487
    Germany

    Site Not Available

  • University Gynecologic Hospital

    Göttingen, 37075
    Germany

    Site Not Available

  • University Gynecologic Hospital

    Göttingen, 37075
    Germany

    Site Not Available

  • Gynecological Clinic of the Medical University

    Hannover, 30659
    Germany

    Site Not Available

  • St. Vincentius Gynecologic Hospital

    Karlsruhe, 76137
    Germany

    Site Not Available

  • University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics

    Kiel, 24105
    Germany

    Site Not Available

  • Otto-von-Guericke University, University Gynecological Hospital

    Magdeburg, 39108
    Germany

    Site Not Available

  • University Gynecologic Hospital "rechts der Isar"

    Muenchen, 81675
    Germany

    Site Not Available

  • University Gynecologic Hospital Grosshadern

    Muenchen, 81377
    Germany

    Site Not Available

  • Clinic for Gynecology

    Muenster, 48149
    Germany

    Site Not Available

  • University Gynecologic Hospital

    Tuebingen, 72076
    Germany

    Site Not Available

  • University Gynecological Hospital

    Ulm, 89075
    Germany

    Site Not Available

  • Clinic for Gnyecology and gyn. Oncology HSK

    Wiesbaden, 65199
    Germany

    Site Not Available

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