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A phase I-II study of high-dose melphalan, mitoxantrone and carboplatin with peripheral blood stem cell support in patients with advanced ovarian or breast carcinoma.
Bone Marrow Transplant. 1997 Nov; 20(10):847-53.BM

Abstract

The purpose of this study was to develop a high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) regimen for treatment of patients with ovarian carcinoma that could be administered in an outpatient setting. Fourteen patients with advanced ovarian (n = 9) or breast (n = 5) carcinoma, who had failed conventional chemotherapy, were entered into a dose-escalation trial to determine the maximum tolerated dose (MTD) of carboplatin that could be administered with fixed doses of melphalan (160 mg/m2) and mitoxantrone (50 mg/m2). Twenty-five additional patients were included in a phase II trial at the MTD. Two of two patients had grade 4 severe regimen-related toxicities (RRT), one fatal, at a dose level of 1600 mg/m2. Two of 29 patients (6.9%) treated at the MTD (carboplatin, 1400 mg/m2) died of RRT. All three patients who died of toxicity had a calculated AUC for carboplatin >30 mg/ml/min. Thirty-one patients with ovarian cancer who had failed chemotherapy were treated, 24 at the MTD. Fourteen of 20 patients (70%) with ovarian carcinoma with evaluable disease achieved a CR and seven (35%) are alive disease-free a median of 20 months (range, 7-26). Five of seven patients with ovarian cancer who had failed chemotherapy but were rendered clinically disease-free following surgery survive without progression a median of 13 months (range, 9-19). Eight of 16 (50%) platinum-resistant and 4/12 (33%) platinum-sensitive patients with ovarian cancer survive disease-free.

Authors+Show Affiliations

Clinical Research Division of Response Oncology, Inc., Memphis, TN, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article

Language

eng

PubMed ID

9404925

Citation

Weaver, C H., et al. "A Phase I-II Study of High-dose Melphalan, Mitoxantrone and Carboplatin With Peripheral Blood Stem Cell Support in Patients With Advanced Ovarian or Breast Carcinoma." Bone Marrow Transplantation, vol. 20, no. 10, 1997, pp. 847-53.
Weaver CH, Greco FA, Hainsworth JD, et al. A phase I-II study of high-dose melphalan, mitoxantrone and carboplatin with peripheral blood stem cell support in patients with advanced ovarian or breast carcinoma. Bone Marrow Transplant. 1997;20(10):847-53.
Weaver, C. H., Greco, F. A., Hainsworth, J. D., Zhen, B., Baldwin, P., Wittlin, F., Lewis, M., West, W. H., Schwartzberg, L., & Buckner, C. D. (1997). A phase I-II study of high-dose melphalan, mitoxantrone and carboplatin with peripheral blood stem cell support in patients with advanced ovarian or breast carcinoma. Bone Marrow Transplantation, 20(10), 847-53.
Weaver CH, et al. A Phase I-II Study of High-dose Melphalan, Mitoxantrone and Carboplatin With Peripheral Blood Stem Cell Support in Patients With Advanced Ovarian or Breast Carcinoma. Bone Marrow Transplant. 1997;20(10):847-53. PubMed PMID: 9404925.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase I-II study of high-dose melphalan, mitoxantrone and carboplatin with peripheral blood stem cell support in patients with advanced ovarian or breast carcinoma. AU - Weaver,C H, AU - Greco,F A, AU - Hainsworth,J D, AU - Zhen,B, AU - Baldwin,P, AU - Wittlin,F, AU - Lewis,M, AU - West,W H, AU - Schwartzberg,L, AU - Buckner,C D, PY - 1997/12/24/pubmed PY - 1997/12/24/medline PY - 1997/12/24/entrez SP - 847 EP - 53 JF - Bone marrow transplantation JO - Bone Marrow Transplant VL - 20 IS - 10 N2 - The purpose of this study was to develop a high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) regimen for treatment of patients with ovarian carcinoma that could be administered in an outpatient setting. Fourteen patients with advanced ovarian (n = 9) or breast (n = 5) carcinoma, who had failed conventional chemotherapy, were entered into a dose-escalation trial to determine the maximum tolerated dose (MTD) of carboplatin that could be administered with fixed doses of melphalan (160 mg/m2) and mitoxantrone (50 mg/m2). Twenty-five additional patients were included in a phase II trial at the MTD. Two of two patients had grade 4 severe regimen-related toxicities (RRT), one fatal, at a dose level of 1600 mg/m2. Two of 29 patients (6.9%) treated at the MTD (carboplatin, 1400 mg/m2) died of RRT. All three patients who died of toxicity had a calculated AUC for carboplatin >30 mg/ml/min. Thirty-one patients with ovarian cancer who had failed chemotherapy were treated, 24 at the MTD. Fourteen of 20 patients (70%) with ovarian carcinoma with evaluable disease achieved a CR and seven (35%) are alive disease-free a median of 20 months (range, 7-26). Five of seven patients with ovarian cancer who had failed chemotherapy but were rendered clinically disease-free following surgery survive without progression a median of 13 months (range, 9-19). Eight of 16 (50%) platinum-resistant and 4/12 (33%) platinum-sensitive patients with ovarian cancer survive disease-free. SN - 0268-3369 UR - https://www.unboundmedicine.com/medline/citation/9404925/A_phase_I_II_study_of_high_dose_melphalan_mitoxantrone_and_carboplatin_with_peripheral_blood_stem_cell_support_in_patients_with_advanced_ovarian_or_breast_carcinoma_ L2 - https://doi.org/10.1038/sj.bmt.1700976 DB - PRIME DP - Unbound Medicine ER -