Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102375
• Other study ID #: AGO-OVAR 7
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2005
• Last updated: August 3, 2006
• Start date: December 1999
• Est. completion date: October 2004

Study information

• Verified date: February 2006
• Source: AGO Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Topotecan

Locations

Country	Name	City	State
Germany	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	Duesseldorf
Germany	University Gynecologic Hospital	Duesseldorf
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	Hannover
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 "rechts der Isar"	Muenchen
Germany	University Gynecologic Hospital Grosshadern	Muenchen
Germany	Clinic for Gynecology	Muenster
Germany	University Gynecologic Hospital	Tuebingen
Germany	University Gynecological Hospital	Ulm
Germany	Clinic for Gnyecology and gyn. Oncology HSK	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
AGO Study Group

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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, Stähle A, Jackisch C, Hardy-Bessard AC, Möbus V, Quaas J, Richter B, Schröder W, Geay JF, Lück HJ, Kuhn W, Meden H, Nitz U, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival
Secondary	Progression-free survival
Secondary	Response rate
Secondary	Response duration
Secondary	Toxicities
Secondary	Quality of Life

External Links

•   Information on studies of the AGO-OVAR on Ovarian cancer