Clinical trial · Interventional
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
NCT00102375CI-TRIAL-00000393completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival
Secondary outcomes (5)
- measure
- Progression-free survival
- measure
- Response rate
- measure
- Response duration
- measure
- Toxicities
- measure
- Quality of Life
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPfisterer 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. PMID 16882940