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 - Article Alkeran; L-PAM
Clinical Trial: 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
This study is currently recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|stage III ovarian epithelial cancer |
stage IV ovarian epithelial cancer
| Drug: carboplatin |
Procedure: adjuvant therapy
Procedure: biological response modifier therapy
Procedure: bone marrow ablation with stem cell support
Procedure: colony-stimulating factor therapy
Procedure: cytokine therapy
Procedure: high-dose chemotherapy
Procedure: peripheral blood stem cell transplantation
|Phase III |
MedlinePlus related topics: Ovarian Cancer
Study Type: Interventional
Study Design: Treatment
- 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.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- 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.
PROJECTED ACCRUAL: A total of 208 patients (104 per treatment arm) will be accrued for this study.
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
- 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
- ECOG 0-2
- Not specified
- Normal hematological function
- Normal hepatic function
- Creatinine clearance greater than 60 mL/min
- GFR greater than 60 mL/min
- No active cardiac disease
- 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
- No prior chemotherapy
- Not specified
- Not specified
- See Disease Characteristics
Location and Contact Information
Sozialmedizinisches Zentrum Ost - Donauspital, Vienna, A-1220, Austria; Recruiting
Centre Hospitalier Notre Dame - Reine Fabiola, Charleroi, 6000, Belgium; Recruiting
Charles University, Prague 10, 10034, Czech Republic; Recruiting
Thomayer Memorial Teaching Hospital, PRAGUE 4, 14000, Czech Republic; Recruiting
Klinikum Nuernberg - Klinikum Nord, Nuernberg, D-90419, Germany; Recruiting
Staedt Klinikum Karlsruhe GGMBH, Karlsruhe, 76133, Germany; Recruiting
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi, Bologna, 40138, Italy; Recruiting
Ospedale San Bortolo, Vicenza, 36100, Italy; Recruiting
Ospedale Santa Chiara, Pisa, 56100, Italy; Recruiting
S. Camillo Hospital, Rome, 00152, Italy; Recruiting
National Cancer Institute - Bratislava, Bratislava, 833 10, Slovakia; Recruiting
Hospital Clinico Universitario de Valencia, Valencia, 46010, Spain; Recruiting
Hospital Universitario San Carlos, Madrid, 28040, Spain; Recruiting
Centre Hospitalier Universitaire Vaudois, Lausanne, CH-1011, Switzerland; Recruiting
United Kingdom, England
Cancer Research Centre at Weston Park Hospital, Manchester, England, M20 9BX, United Kingdom; Recruiting
Cancer Research UK and University College London Cancer Trials Centre, London, England, NW1 2ND, United Kingdom; Recruiting
St. James's University Hospital at Leeds Teaching Hospital NHS Trust, Leeds, England, LS9 7TF, United Kingdom; Recruiting
Jonathan A. Ledermann, MD, Study Chair, Cancer Research UK
Record last reviewed: October 2003
Last Updated: April 4, 2005
Record first received: March 7, 2000
ClinicalTrials.gov Identifier: NCT00004921
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005