High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery

NCT00004921 | Completed Phase 3

• 4 other identifiers: CDR0000067604EBMT-HIDOC-EISEBMT-OVCATEU-99040
• Study Type: interventional
• Target: N/A
• Locations: 9 countries
• Sites: 17

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 which chemotherapy regimen is most effective for ovarian epithelial cancer. PURPOSE: This randomized phase III trial is studying high-dose chemotherapy to see how well it works compared to standard chemotherapy in treating patients with stage III or stage IV ovarian epithelial cancer that has been removed during surgery.

Conditions

Ovarian Cancer

Keywords

stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer

Interventions

filgrastim BIOLOGICAL

carboplatin DRUG

cyclophosphamide DRUG

melphalan DRUG

paclitaxel DRUG

adjuvant therapy PROCEDURE

bone marrow ablation with stem cell support PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV ovarian epithelial cancer * Bilateral salpingo-oophorectomy, hysterectomy, and omentectomy within 6 weeks of study * Less than 2 cm maximum diameter of residual tumor remaining PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Normal hematological function Hepatic: * Normal hepatic function Renal: * Creatinine clearance greater than 60 mL/min * GFR greater than 60 mL/min Cardiovascular: * No active cardiac disease Other: * No other uncontrolled serious medical illness, including hearing problems * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics

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

Sponsors & Collaborators

• EBMT Solid Tumors Working Party: lead

Study Sites (17)

Sozialmedizinisches Zentrum Ost - Donauspital

Vienna, A-1220, Austria

Location

Centre Hospitalier Notre Dame - Reine Fabiola

Charleroi, 6000, Belgium

Location

Charles University

Prague, 10034, Czechia

Location

Thomayer Memorial Teaching Hospital

Prague, 14000, Czechia

Location

Staedt Klinikum Karlsruhe GGMBH

Karlsruhe, 76133, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90419, Germany

Location

Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi

Bologna, 40138, Italy

Location

Ospedale Santa Chiara

Pisa, 56100, Italy

Location

S. Camillo Hospital

Rome, 00152, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Cancer Research UK and University College London Cancer Trials Centre

London, England, NW1 2ND, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Manchester, England, M20 9BX, United Kingdom

Location

Related Publications (1)

• Mobus V, Wandt H, Frickhofen N, Bengala C, Champion K, Kimmig R, Ostermann H, Hinke A, Ledermann JA; AGO-Ovar/AIO; EBMT. Phase III trial of high-dose sequential chemotherapy with peripheral blood stem cell support compared with standard dose chemotherapy for first-line treatment of advanced ovarian cancer: intergroup trial of the AGO-Ovar/AIO and EBMT. J Clin Oncol. 2007 Sep 20;25(27):4187-93. doi: 10.1200/JCO.2006.09.7527. Epub 2007 Aug 13.

  PMID: 17698804 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Filgrastim; Carboplatin; Cyclophosphamide; Melphalan; Paclitaxel; Chemotherapy, Adjuvant; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics; Drug Therapy; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Transplantation; Surgical Procedures, Operative

Study Officials

• Jonathan A. Ledermann, MD

  Cancer Research UK

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: January 27, 2003
• Study Start: September 1, 1998
• Study Completion: September 1, 2007
• Last Updated: September 17, 2013

Record last verified: 2002-07

Locations

DE (2); SL (1); ES (2); BE (1); CH (1); CZ (2); IT (4); AU (1); GB (3)