Back to resultsPaclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Topotecan
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer, first-line, Topotecan
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
Sites / Locations
- Gynecologic Hospital of the Medical Facilities RWTH
- Clinic for Gynecology and Gyn. Oncology, Humboldt University
- University Clinic Carl Gustav Carus, Gynecological hospital
- Gynecologic Hospital
- University Gynecologic Hospital
- University Gynecologic Hospital
- Gynecologic Clinic of the Ernst-Moritz-Arndt-University
- University Gynecologic Hospital
- Gynecological Clinic of the Medical University
- St. Vincentius Gynecologic Hospital
- University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
- Otto-von-Guericke University, University Gynecological Hospital
- University Gynecologic Hospital Grosshadern
- University Gynecologic Hospital "rechts der Isar"
- Clinic for Gynecology
- University Gynecologic Hospital
- University Gynecological Hospital
- Clinic for Gnyecology and gyn. Oncology HSK
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
Progression-free survival
Response rate
Response duration
Toxicities
Quality of Life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00102375
Brief Title
Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AGO Study Group
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian Cancer, first-line, Topotecan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topotecan
Primary Outcome Measure Information:
Title
Survival
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Response rate
Title
Response duration
Title
Toxicities
Title
Quality of Life
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobus Pfisterer, Prof. Dr.
Organizational Affiliation
AGO Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Hospital of the Medical Facilities RWTH
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Clinic for Gynecology and Gyn. Oncology, Humboldt University
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
University Clinic Carl Gustav Carus, Gynecological hospital
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Gynecologic Hospital
City
Duesseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
University Gynecologic Hospital
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
University Gynecologic Hospital
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Gynecologic Clinic of the Ernst-Moritz-Arndt-University
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
Facility Name
University Gynecologic Hospital
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Gynecological Clinic of the Medical University
City
Hannover
ZIP/Postal Code
30659
Country
Germany
Facility Name
St. Vincentius Gynecologic Hospital
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Otto-von-Guericke University, University Gynecological Hospital
City
Magdeburg
ZIP/Postal Code
39108
Country
Germany
Facility Name
University Gynecologic Hospital Grosshadern
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
University Gynecologic Hospital "rechts der Isar"
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Clinic for Gynecology
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
University Gynecologic Hospital
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
University Gynecological Hospital
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Clinic for Gnyecology and gyn. Oncology HSK
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16882940
Citation
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.
Results Reference
result
Links:
URL
http://www.ago-ovar.de
Description
Information on studies of the AGO-OVAR on Ovarian cancer
Learn more about this trial
Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
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