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.
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
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
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
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
- Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or
adenocarcinoma of the cervix
- Stage IVB, recurrent, or persistent disease
- Not amenable to curative surgery and/or radiotherapy
- At least 1 unidimensionally measurable lesion
- At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by
spiral CT scan
- Biopsy confirmation required if lesion is less than 30 mm
- Target lesion must be outside of a previously irradiated field
- No craniospinal metastases
- Performance status - GOG 0-1
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times normal
- Alkaline phosphatase no greater than 3 times normal
- AST no greater than 3 times normal
- Creatinine ≤ 1.2 mg/dL
- Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min
- No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior or concurrent malignancy within the past 5 years except nonmelanoma skin
- No prior malignancy whose treatment contraindicates the current study therapy
- No concurrent clinically significant infection
- No concurrent cytokines
- At least 6 weeks since prior chemoradiotherapy and recovered
- No prior chemotherapy (except when concurrently administered with radiotherapy)
- At least 3 weeks since prior radiotherapy and recovered
- Recovered from prior surgery