Cervical Adenocarcinoma Clinical Trial
Official title:
A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix
This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.
PRIMARY OBJECTIVES:
I. Compare the survival and response of patients with stage IVB, recurrent, or persistent
carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and
cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
II. Compare the toxic effects of these regimens in these patients. III. Compare the quality
of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment
arms.
ARM I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours
on day 2.
ARM II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV
over 1-4 hours on day 1.
ARM III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as
in arm II.
ARM IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
In all arms, treatment repeats every 21 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study
entry.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
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