Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer

NCT00006454 | Completed Phase 3 DMC

• 3 other identifiers: CDR0000067994AGOSG-OVAR-7NCI-V00-1602
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 19

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if paclitaxel plus carboplatin is more effective with or without topotecan for ovarian epithelial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer.

Conditions

Fallopian Tube Cancer; Ovarian Cancer

Keywords

stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; fallopian tube cancer

Interventions

carboplatin DRUG

paclitaxel DRUG

topotecan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed stage IIB, III, or IV ovarian epithelial carcinoma, fallopian tube, or extraovarian papillary serous carcinoma extending to the ovary No mixed epithelial/non-epithelial tumors (e.g., mixed Mullerian tumors) No tumors of low malignant potential (e.g., borderline tumors) No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.25 times ULN Estimated glomerular filtration rate at least 60 mL/min Cardiovascular: No history of congestive heart failure (even if medically controlled) No New York Heart Association class III or IV heart disease No myocardial infarction within the past 6 months No history of atrial or ventricular arrhythmias Other: No motor or sensory neurologic pathology or symptoms greater than grade 1 No active infection or other serious medical condition that would preclude study No prior allergy to drug containing Cremophor EL No dementia or significantly altered mental state that would preclude informed consent No complete bowel obstruction No other prior malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent WBC transfusions Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: No more than 6 weeks since prior definitive laparotomy and recovered Other: No other concurrent antineoplastic agents No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AGO Study Group: lead

Study Sites (19)

Universitaetsklinikum Charite

Berlin, D-10117, Germany

Location

Universitaetskliniken Bonn

Bonn, D-53105, Germany

Location

Zentralkrankenhaus

Bremen, D-28205, Germany

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

Universitaetsklinik Duesseldorf

Düsseldorf, D-40225, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, DOH-4-0217, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Stadtische Kliniken Frankfurt-Hochst

Frankfurt, DOH-6-5929, Germany

Location

Universitaetsklinik Goettingen

Göttingen, D-37075, Germany

Location

Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17487, Germany

Location

Frauenklinik der MHH

Hanover, 30659, Germany

Location

Vincentius Krankenhaus

Karlsruhe, D-76137, Germany

Location

Christian-Albrechts University of Kiel

Kiel, D-24105, Germany

Location

Klinik der Otto-v.-Guericke-Universitat

Magdeburg, 39108, Germany

Location

Klinikum Grosshadern

Munich, D-81377, Germany

Location

Klinikum Rechts Der Isar/Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Klinik und Poliklinik fuer Kinderheilkunde

Münster, D-48129, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Related Publications (3)

• Greimel ER, Bjelic-Radisic V, Pfisterer J, Hilpert F, Daghofer F, Pujade-Lauraine E, du Bois A; Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR); Groupe d'Investigateurs Nationaux pour les Etudes des Cancers de l'Ovaire (GINECO). Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials. Support Care Cancer. 2011 Sep;19(9):1421-7. doi: 10.1007/s00520-010-0969-8. Epub 2010 Aug 6.

  PMID: 20694564 BACKGROUND

• 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.

  PMID: 16882940 RESULT

• Pfisterer J, Lortholary A, Kimmig R, et al.: Paclitaxel/carboplatin (TC) vs. paclitaxel/carboplatin followed by topotecan (TC-Top) in first-line treatment of ovarian cancer FIGO stages IIb - IV. Interim results of a gynecologic cancer intergroup phase III trial of the AGO Ovarian Cancer Study Group and GINECO. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1793, 446, 2003.

  RESULT

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Paclitaxel; Topotecan

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Jacobus Pfisterer, MD

  University Hospital Schleswig-Holstein

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: February 3, 2004
• Study Start: December 1, 1999
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

DE (19)