Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

NCT ID: NCT00102375

Last Updated: 2006-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2004-10-31

Brief 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.

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

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; first-line; Topotecan

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Topotecan

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AGO Study Group

OTHER

Sponsor Role: lead

Principal Investigators

Jacobus Pfisterer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

AGO Study Group

Locations

Gynecologic Hospital of the Medical Facilities RWTH

Aachen, , Germany

Clinic for Gynecology and Gyn. Oncology, Humboldt University

Berlin, , Germany

University Clinic Carl Gustav Carus, Gynecological hospital

Dresden, , Germany

Gynecologic Hospital

Düsseldorf, , Germany

University Gynecologic Hospital

Düsseldorf, , Germany

University Gynecologic Hospital

Frankfurt, , Germany

University Gynecologic Hospital

Göttingen, , Germany

Gynecologic Clinic of the Ernst-Moritz-Arndt-University

Greifswald, , Germany

Gynecological Clinic of the Medical University

Hanover, , Germany

St. Vincentius Gynecologic Hospital

Karlsruhe, , Germany

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

Kiel, , Germany

Otto-von-Guericke University, University Gynecological Hospital

Magdeburg, , Germany

University Gynecologic Hospital Grosshadern

München, , Germany

University Gynecologic Hospital "rechts der Isar"

München, , Germany

Clinic for Gynecology

Münster, , Germany

University Gynecologic Hospital

Tübingen, , Germany

University Gynecological Hospital

Ulm, , Germany

Clinic for Gnyecology and gyn. Oncology HSK

Wiesbaden, , Germany

Countries

Germany

References

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. doi: 10.1093/jnci/djj296.

Reference Type: RESULT

PMID: 16882940 (View on PubMed)

Related Links

http://www.ago-ovar.de

Information on studies of the AGO-OVAR on Ovarian cancer

Other Identifiers

AGO-OVAR 7

Identifier Type: -

Identifier Source: org_study_id