Phase II trial of hydroxyurea, dacarbazine (DTIC), and etoposide (VP-16) in mixed mesodermal tumors of the uterus: a Gynecologic Oncology Group study.
OBJECTIVE
The purpose of this study was to evaluate the efficacy of this three-drug regimen--hydroxyurea, dacarbazine (DTIC), and etoposide (VP-16)--in patients with advanced or recurrent mixed mesodermal tumors (MMT) of the uterus who had not undergone previous chemotherapy. The study was performed as a groupwide phase II study of the Gynecologic Oncology Group.


METHODS
Thirty-three evaluable patients received hydroxyurea 2 g in divided doses on Day 1, 700 mg/m2 DTIC and 100 mg/m2 VP-16 on Day 2, and VP-16 100 mg/m2 on Days 3 and 4. Thirty-two patients were evaluable for response. Twenty-six patients had previously undergone abdominal hysterectomy and 11 had received prior radiation therapy, for whom one dose level reduction of the first course was required.


RESULTS
Two patients exhibited complete response and three patients showed partial responses for an overall response rate of 15.7% (95% confidence interval: 5.3-32.8%). Seventeen of 32 patients had stable disease on therapy. Toxicity was acceptable and there were no treatment-related deaths.


CONCLUSIONS
This regimen reveals moderate activity in patients with advanced or recurrent MMT.
Currie
J L
JL
Department of Obstetrics and Gynecology, Johns Hopkins Hospital, Baltimore, Maryland 21205, USA.
Blessing
J A
JA
McGehee
R
R
Soper
J T
JT
Berman
M
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003606:Dacarbazine / Q000008:administration & dosage; D018450:Disease Progression; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage; D008875:Middle Aged; D018199:Mixed Tumor, Mesodermal / Q000188:drug therapy*; D009364:Neoplasm Recurrence, Local; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000188:drug therapy*
D005047:Etoposide; D003606:Dacarbazine; D006918:Hydroxyurea