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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006454
First received: November 6, 2000
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Drug: carboplatin
Drug: paclitaxel
Drug: topotecan hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1999
Detailed Description:

OBJECTIVES: I. Compare survival of patients with stage IIB, III, or IV ovarian epithelial carcinoma after receiving treatment with paclitaxel and carboplatin with or without topotecan. II. Compare progression-free survival of these patients after receiving these treatment regimens. III. Compare the response rate and response duration in these patients treated with these regimens. IV. Determine the toxic effects of the combination of paclitaxel, carboplatin, and topotecan in these patients. V. Compare the toxic effects of these treatment regimens in these patients. VI. Compare quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and stage (stage IIB and stage III optimally debulked to no greater than 1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater than 1 cm). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 0.5-1 hour on day 1 and topotecan IV over 0.5 hour on days 1-5. Treatment repeats every 21 days for 6 courses (topotecan is administered for 4 courses only). Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment repeats every 21 days for 6 courses. Quality of life is assessed before courses 1, 3, and 5 and at 3 weeks and 3 months after completion of treatment in both treatment arms; before courses 1 and 3 of topotecan in arm I; and at 6 months after completion of treatment in arm II. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 914 patients (457 per treatment arm) will be accrued for this study over 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00006454

Locations
Germany
Universitaetsklinikum Charite
Berlin, Germany, D-10117
Universitaetskliniken Bonn
Bonn, Germany, D-53105
Zentralkrankenhaus
Bremen, Germany, D-28205
Medizinische Klinik I
Dresden, Germany, D-01307
Universitaetsklinik Duesseldorf
Duesseldorf, Germany, D-40225
Evangelisches Krankenhaus
Dusseldorf, Germany, DOH-4-0217
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Stadtische Kliniken Frankfurt-Hochst
Frankfurt, Germany, DOH-6-5929
Universitaetsklinik Goettingen
Gottingen, Germany, D-37075
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, Germany, D-17487
Frauenklinik der MHH
Hannover, Germany, 30659
Vincentius Krankenhaus
Karlsruhe, Germany, D-76137
Christian-Albrechts University of Kiel
Kiel, Germany, D-24105
Klinik der Otto-v.-Guericke-Universitat
Magdeburg, Germany, 39108
Klinik und Poliklinik fuer Kinderheilkunde
Muenster, Germany, D-48129
Klinikum Grosshadern
Munich, Germany, D-81377
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, Germany, D-81675
Universitaetsklinikum Tuebingen
Tuebingen, Germany, D-72076
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, D-65199
Sponsors and Collaborators
AGO Study Group
Investigators
Study Chair: Jacobus Pfisterer, MD University of Schleswig-Holstein
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006454     History of Changes
Other Study ID Numbers: CDR0000067994, AGOSG-OVAR-7, NCI-V00-1602
Study First Received: November 6, 2000
Last Updated: August 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Neoplasms by Histologic Type
Carboplatin
Paclitaxel
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014