Cervical Cancer Clinical Trial
Official title:
A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells. It is
not yet known which chemotherapy regimen is more effective for cervical cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of three different
chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical
cancer.
OBJECTIVES:
- Compare the response rate and survival of patients with stage IVB, recurrent, or
persistent carcinoma of the cervix treated with cisplatin only vs cisplatin plus
topotecan vs methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC). (Arm III
(MVAC) closed to accrual effective 07/23/2001.)
- Compare the toxic effects of these regimens in this patient population.
- Compare health-related quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to GOG
performance status. Patients are randomized to one of three treatment arms. (Arm III closed
to accrual effective 07/23/2001.)
- Arm I: Patients receive cisplatin IV once every 21 days.
- Arm II:Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin IV
(beginning after topotecan infusion) on day 1. Courses repeat every 21 days.
- Arm III:Patients receive methotrexate IV on days 1, 15, and 22, vinblastine IV on days
2, 15, and 22, and doxorubicin IV and cisplatin IV on day 2. Courses repeat every 28
days. (Arm III closed to accrual effective 07/23/2001.) Treatment in all arms continues
for a maximum of 6 courses in the absence of disease progression or unacceptable
toxicity. (Arm III closed to accrual effective 07/23/2001.)
Quality of life is assessed before randomization, before course 2, before course 5 (arms I
and II), before course 4 (arm III), and at 9 months. (Arm III closed to accrual effective
07/23/2001.)
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients (133 per treatment arm) will be accrued for this
study within 2 years. (Arm III closed to accrual effective 07/23/2001.)
;
Allocation: Randomized, Primary Purpose: Treatment
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