NCT00002474
Combination Chemotherapy and Bone Marrow Transplant in Treating Patients With Refractory or Recurrent Ovarian Cancer
PHASE2
COMPLETED
NCT00002474
INTERVENTIONAL
Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
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.
DISEASE CHARACTERISTICS:
* Diagnosis of refractory or relapsed ovarian epithelial cancer
* Must have failed prior regimen containing cisplatin or carboplatin
* Bidimensionally measurable or evaluable disease
* Serial CA-125 antigen titers or cytologically positive pleural effusion and/or ascites acceptable as evaluable disease
* Autologous bone marrow harvest of greater than 1.2 x 10 to the eighth nucleated cells/kg required before study entry
* No evidence of tumor at marrow harvest sites by bilateral bone marrow aspirates and biopsies, pelvic x-ray, and bone scan
* CNS involvement allowed
PATIENT CHARACTERISTICS:
Age:
* Under 65
Performance status:
* SWOG 0-2
Life expectancy:
* At least 8 weeks
Hematopoietic:
* WBC greater than 3,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10.0 g/dL
Hepatic:
* Bilirubin less than 2.0 mg/dL
* SGOT and SGPT less than 2 times upper limit of normal
Renal:
* Creatinine clearance greater than 60 mL/min
* No prior hemorrhagic cystitis
Cardiovascular:
* LVEF greater than 45% by MUGA scan
Other:
* No hearing loss in voice tones
* No active infection
* No psychological contraindication to study treatment
* Not pregnant
* Negative pregnancy test
* HIV negative
* General medical condition must allow general anesthesia
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No prior bone marrow transplantation
* More than 4 weeks since other prior biologic therapy and recovered
Chemotherapy:
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* More than 4 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Ovarian Cancer
- TREATMENT
-
- Type: DRUG
- Name: carboplatin
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: cyclophosphamide
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: mitoxantrone hydrochloride
- Description:
- Arm Group Labels:
-
- Type: PROCEDURE
- Name: autologous bone marrow transplantation
- Description:
- Arm Group Labels:
-
- Type: PROCEDURE
- Name: bone marrow ablation with stem cell support
- Description:
- Arm Group Labels:
- Loyola University