Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 to 65 Other EBMT-HIDOC-EIS EBMT-OVCAT, EU-99040, NCT00004921

Objectives

1. Compare the two-year progression-free survival in patients with optimally debulked stage III or IV ovarian epithelial cancer undergoing high-dose sequential chemotherapy vs standard chemotherapy.
2. Compare the overall survival, toxicity, and quality of life in this patient population receiving these two treatment regimens.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

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

Expected Enrollment

A total of 208 patients (104 per treatment arm) will be accrued for this study.

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive 5 courses of sequential high-dose chemotherapy as follows:
  • Courses 1 and 2: Patients receive paclitaxel IV over 3 hours and cyclophosphamide IV over 2 hours on day 1 followed by peripheral blood stem cell (PBSC) collection. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours following chemotherapy and continuing until target number of PBSC are reached.
  
  
  
  • Courses 3 and 4: Patients receive paclitaxel as in courses 1-2 and carboplatin IV over 4 hours on day 1. At 72 hours following completion of carboplatin, patients receive PBSC infusion. Beginning one day following PBSC infusion, patients receive G-CSF SC until blood counts recover.
  
  
  
  • Course 5: Patients receive paclitaxel as in courses 1 and 2 and carboplatin as in courses 3 and 4 and melphalan IV over 15 minutes on day 2 or 3. Patients receive PBSC and G-CSF as in courses 3 and 4.
  
  
  
  • Treatment repeats every 3-4 weeks.
  
  
  



• Arm II: Patients receive standard chemotherapy consisting of carboplatin (or cisplatin) and paclitaxel IV over 3 hours every 3 weeks for 6 courses. Patients may receive doxorubicin or epirubicin in addition to the standard chemotherapy every 4 weeks.

Quality of life is assessed prior to therapy, at 4-6 weeks following completion of therapy, and then at 3 months, 9 months, and 15 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Möbus V, Wandt H, Frickhofen N, et al.: 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 25 (27): 4187-93, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

EBMT Solid Tumors Working Party

Jonathan Ledermann, MD, Protocol chair		Ph: 44-20-7679-8040 Email: j.ledermann@ctc.ucl.ac.uk

Registry Information
Official Title		A Randomized Phase III Trial of Sequential High Dose Chemotherapy or Standard Chemotherapy for Optimally Debulked FIGO Stage III and IV Ovarian Cancer
Trial Start Date		1998-09-01
Registered in ClinicalTrials.gov		NCT00004921
Date Submitted to PDQ		2000-01-13
Information Last Verified		2002-07-02

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