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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004921
• Other study ID #: CDR0000067604
• Secondary ID: EBMT-HIDOC-EISEB
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2000
• Last updated: September 16, 2013
• Start date: September 1998
• Est. completion date: September 2007

Study information

• Verified date: July 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• carboplatin

• cyclophosphamide

• melphalan

• paclitaxel

Procedure:
• adjuvant therapy

• bone marrow ablation with stem cell support

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
Austria	Sozialmedizinisches Zentrum Ost - Donauspital	Vienna
Belgium	Centre Hospitalier Notre Dame - Reine Fabiola	Charleroi
Czech Republic	Charles University	Prague 10
Czech Republic	Thomayer Memorial Teaching Hospital	Prague 4
Germany	Staedt Klinikum Karlsruhe GGMBH	Karlsruhe
Germany	Klinikum Nuernberg - Klinikum Nord	Nuernberg
Italy	Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi	Bologna
Italy	Ospedale Santa Chiara	Pisa
Italy	S. Camillo Hospital	Rome
Italy	Ospedale San Bortolo	Vicenza
Slovakia	National Cancer Institute - Bratislava	Bratislava
Spain	Hospital Universitario San Carlos	Madrid
Spain	Hospital Clinico Universitario de Valencia	Valencia
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Cancer Research UK and University College London Cancer Trials Centre	London	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
EBMT Solid Tumors Working Party

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Germany,  Italy,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

Möbus 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 — View Citation