Combination Chemotherapy and Bone Marrow Transplant in Treating Patients With Refractory or Recurrent Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT00002474|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 30, 2013
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, carboplatin, and mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with autologous bone marrow transplant may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy and autologous bone marrow transplant work in treating patients with refractory or recurrent ovarian cancer.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: carboplatin Drug: cyclophosphamide Drug: mitoxantrone hydrochloride Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support||Phase 2|
- Determine the response rate, duration of response, and overall survival of patients with refractory or relapsed ovarian epithelial cancer treated with high-dose cyclophosphamide, carboplatin, and mitoxantrone followed by autologous bone marrow transplantation.
- Determine the nonhematopoietic toxicity of this regimen in these patients.
OUTLINE: Autologous bone marrow is harvested before study entry. Patients receive high-dose cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4 and carboplatin IV continuously on days -8 to -3 in the absence of unacceptable toxicity. Bone marrow is reinfused on day 0 beginning at least 60 hours after completion of carboplatin infusion.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1.5-3 years.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma|
|Study Start Date :||February 1991|
|Study Completion Date :||October 2005|
U.S. FDA Resources
- Response rate
- Response duration
- Overall survival
- Nonhematopoietic toxicity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002474
|United States, Illinois|
|Cardinal Bernardin Cancer Center at Loyola University Medical Center|
|Maywood, Illinois, United States, 60153-5500|
|Study Chair:||Patrick J. Stiff, MD||Loyola University|