Clinical trial NCT00102375: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
first-line
Topotecan
Lead sponsor: AGO Study Group
Sponsor class: OTHER
First posted: 2005-01-31
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Survival
Secondary outcomes:
measure: Progression-free survival
measure: Response rate
measure: Response duration
measure: Toxicities
measure: Quality of Life
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Gynecologic Hospital of the Medical Facilities RWTH
city: Berlin
country: Germany
facility: Clinic for Gynecology and Gyn. Oncology, Humboldt University
city: Dresden
country: Germany
facility: University Clinic Carl Gustav Carus, Gynecological hospital
city: Duesseldorf
country: Germany
facility: Gynecologic Hospital
city: Duesseldorf
country: Germany
facility: University Gynecologic Hospital
city: Frankfurt
country: Germany
facility: University Gynecologic Hospital
city: Greifswald
country: Germany
facility: Gynecologic Clinic of the Ernst-Moritz-Arndt-University
city: Göttingen
country: Germany
facility: University Gynecologic Hospital
city: Hannover
country: Germany
facility: Gynecological Clinic of the Medical University
city: Karlsruhe
country: Germany
facility: St. Vincentius Gynecologic Hospital
city: Kiel
country: Germany
facility: University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
city: Magdeburg
country: Germany
facility: Otto-von-Guericke University, University Gynecological Hospital
city: Muenchen
country: Germany
facility: University Gynecologic Hospital Grosshadern
city: Muenchen
country: Germany
facility: University Gynecologic Hospital "rechts der Isar"
city: Muenster
country: Germany
facility: Clinic for Gynecology
city: Tuebingen
country: Germany
facility: University Gynecologic Hospital
city: Ulm
country: Germany
facility: University Gynecological Hospital
city: Wiesbaden
country: Germany
facility: Clinic for Gnyecology and gyn. Oncology HSK
Study officials:
affiliation: AGO Study Group
name: Jacobus Pfisterer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.