Phase II trial of amonafide in previously treated patients with advanced ovarian cancer: a Southwest Oncology Group study.
Twenty-three patients with metastatic or recurrent Stage III or IV epithelial ovarian cancer who were refractory to or relapsed following previous chemotherapy with cisplatin or a cisplatin analog were entered into a phase II study of amonafide. The starting dose of amonafide was 300 mg/m2 delivered daily over 1 hr by intravenous infusion. In the absence of myelosuppression, the dose of amonafide was escalated by increments of 75 mg/m2 to a maximum of 450 mg/m2. There were 19 eligible and 17 fully evaluable patients. Grade 3 or 4 leukopenia occurred in 14 (74%) patients and grade 3 or 4 thrombocytopenia in 6 (32%) patients. No objective complete or partial responses were observed. Four patients had stable disease for 3, 4, 4.5, and 6 months, respectively. Therefore, amonafide in the doses used in the present trial does not have significant activity in previously treated patients with ovarian cancer.
Gallion
H H
HH
University of Kentucky Medical Center, Lexington.
Liu
P Y
PY
Alberts
D E
DE
O'Toole
R V
RV
O'Sullivan
J
J
Mills
G
G
Smith
H O
HO
Hynes
H E
HE
D000225:Adenine; D000328:Adult; D000368:Aged; D002945:Cisplatin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007094:Imides; D007546:Isoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D053644:Naphthalimides; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009367:Neoplasm Staging; D063065:Organophosphonates; D010051:Ovarian Neoplasms / Q000188:drug therapy*
D007094:Imides; D007546:Isoquinolines; D053644:Naphthalimides; D063065:Organophosphonates; C037020:amonafide; D000225:Adenine; D002945:Cisplatin