Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma (Cancer) of the Cervix

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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 regimen. Secondary 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 best response. 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.

Official Title
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Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age Over 18 Performance status GOG 0-2 Life expectancy More than 6 months Hematopoietic Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 8 g/dL Hepatic Bilirubin normal SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR Alkaline phosphatase ≤ 4 times ULN AND SGOT and SGPT normal Renal Creatinine < 1.5 times ULN Other No other invasive malignancy within the past 5 years No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 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 participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic therapy Chemotherapy 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 Endocrine therapy At least 4 weeks since prior hormonal therapy Radiotherapy See Chemotherapy At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery At least 3 weeks since prior major surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|30 minute infusion dosed based on glomerular filtration rate of patient|
|Drug: docetaxel|escalating doses ofstarting at 25 milligrams per meter squared|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of docetaxel |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IVB cervical cancer, recurrent cervical cancer, cervical squamous cell carcinoma