RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different
ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with
carboplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when
given together with carboplatin and to see how well they work in treating patients with
recurrent stage IVB squamous cell carcinoma (cancer) of the cervix.
- Determine the maximum tolerated dose of docetaxel when administered with carboplatin in
patients with recurrent stage IVB squamous cell carcinoma of the cervix.
- Determine the response rate and time to progression in patients treated with this
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is phase I, dose-escalation study of docetaxel followed by a phase II study.
- Phase I: Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30
minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in
the absence of disease progression or unacceptable toxicity. Patients who demonstrate
continuing tumor shrinkage after 6 courses receive 2 additional courses beyond their
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive docetaxel and carboplatin as in phase I at the MTD
determined in phase I.
Quality of life is assessed at baseline, before every other course of treatment, and at the
end of study treatment.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 16-40 for phase II) will
be accrued for this study within 2 years.
- Histologically confirmed squamous cell carcinoma of the uterine cervix
- Advanced disease (stage IVB)
- Persistent or recurrent disease
- No available curative treatment options
- Measurable disease by physical examination, chest x-ray, CT scan, or MRI
- Over 18
- GOG 0-2
- More than 6 months
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 8 g/dL
- Bilirubin normal
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal
- Alkaline phosphatase ≤ 4 times ULN AND SGOT and SGPT normal
- Creatinine < 1.5 times ULN
- No other invasive malignancy within the past 5 years
- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with
- No peripheral neuropathy > grade 1
- No other concurrent malignancy except curatively treated non-melanoma skin cancer
- No other serious medical or psychiatric illness that would preclude giving informed
consent or limit survival
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
- No concurrent biologic therapy
- No more than 2 prior chemotherapy regimens
- One sensitizing chemotherapy regimen during radiotherapy AND 1 regimen for
recurrent disease are considered 2 regimens
- At least 4 weeks since prior chemotherapy
- No prior docetaxel
- No prior carboplatin
- No other concurrent chemotherapy
- At least 4 weeks since prior hormonal therapy
- See Chemotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- At least 3 weeks since prior major surgery