Phase II trial of thio-TEPA in relapsed and refractory ovarian carcinoma.
On the basis of a Phase I reevaluation of thio-TEPA in which 3 of 9 patients with ovarian carcinoma responded, we instituted a Phase II study at high doses. Fourteen patients with a histologic diagnosis of epithelial carcinoma of the ovary, who had received at least one prior cisplatin-based regimen, were entered. Thio-TEPA was initially administered intravenously at a dose of 65 mg/m2 every 4 weeks, but was reduced to 50 mg/m2 after severe myelotoxicity developed in the first 5 patients. In 4 patients stable disease lasted 3, 4, 5, and 9 months; 10 patients progressed. There were no objective responses. At this dose and schedule, thio-TEPA has a response rate less than 20% in ovarian cancer patients previously treated with cisplatin.
Langer
C J
CJ
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111.
Nash
S
S
Catalano
R
R
Rosenblum
N G
NG
Hogan
W M
WM
Comis
R L
RL
O'Dwyer
P J
PJ
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000380:Agranulocytosis / Q000139:chemically induced; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D013852:Thiotepa / Q000009:adverse effects / Q000627:therapeutic use*; D013921:Thrombocytopenia / Q000139:chemically induced
D013852:Thiotepa