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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

January 29, 2005
August 3, 2006
December 1999
Not Provided
Survival
Same as current
Complete list of historical versions of study NCT00102375 on ClinicalTrials.gov Archive Site
  • Progression-free survival
  • Response rate
  • Response duration
  • Toxicities
  • Quality of Life
Same as current
Not Provided
Not Provided
 
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: Topotecan
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
October 2004
Not Provided

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00102375
AGO-OVAR 7
Not Provided
Not Provided
AGO Study Group
Not Provided
Principal Investigator: Jacobus Pfisterer, Prof. Dr. AGO Study Group
AGO Study Group
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP