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| Sponsored by: |
Loyola University |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002474 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: mitoxantrone hydrochloride Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, 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 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | up to 64 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of refractory or relapsed ovarian epithelial cancer
Bidimensionally measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000076845, LUMC-3007, NCI-V91-0058 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002474 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer |
|
Ovarian Neoplasms Immunologic Factors Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Carboplatin Cyclophosphamide Ovarian Diseases Ovarian Epithelial Cancer Immunosuppressive Agents Recurrence |
Carcinoma Genital Diseases, Female Ovarian Cancer Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Mitoxantrone Endocrinopathy Antirheumatic Agents Alkylating Agents Endocrine Gland Neoplasms |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Ovarian Diseases Genital Diseases, Female Neoplasms by Site Sensory System Agents Therapeutic Uses Analgesics Alkylating Agents Endocrine Gland Neoplasms |
Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Carboplatin Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Myeloablative Agonists Peripheral Nervous System Agents Mitoxantrone Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents |