Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information
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
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | 18 to 65 | Other | EBMT-HIDOC-EIS EBMT-OVCAT, EU-99040, NCT00004921 |
Objectives
- 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.
- 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.
Published ResultsMöbus 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 Lead Organizations
EBMT Solid Tumors Working Party
 | | | ||
| Jonathan Ledermann, MD, Protocol chair | |
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| Registry Information | ||
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| 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 | |
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| Trial Start Date | 1998-09-01 | |
| ||
| Registered in ClinicalTrials.gov | NCT00004921 | |
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| Date Submitted to PDQ | 2000-01-13 | |
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| Information Last Verified | 2002-07-02 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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