Clinical trial · Interventional
Combination Chemotherapy and Bone Marrow Transplant in Treating Patients With Refractory or Recurrent Ovarian Cancer
Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Response rate
- measure
- Response duration
- measure
- Overall survival
- measure
- Nonhematopoietic toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTStiff PJ, Bayer R, Kerger C, Potkul RK, Malhotra D, Peace DJ, Smith D, Fisher SG. High-dose chemotherapy with autologous transplantation for persistent/relapsed ovarian cancer: a multivariate analysis of survival for 100 consecutively treated patients. J Clin Oncol. 1997 Apr;15(4):1309-17. doi: 10.1200/JCO.1997.15.4.1309. PMID 9193322
- RESULTStiff P, Bayer R, Camarda M, Tan S, Dolan J, Potkul R, Loutfi S, Kinch L, Sosman J, Peace D, et al. A phase II trial of high-dose mitoxantrone, carboplatin, and cyclophosphamide with autologous bone marrow rescue for recurrent epithelial ovarian carcinoma: analysis of risk factors for clinical outcome. Gynecol Oncol. 1995 Jun;57(3):278-85. doi: 10.1006/gyno.1995.1143. PMID 7774830