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

Phase 1TerminatedNCT00084890

Wake Forest University Health Sciences15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Cervical Cancer

Interventions

carboplatinDRUG

30 minute infusion dosed based on glomerular filtration rate of patient

docetaxelDRUG

escalating doses ofstarting at 25 milligrams per meter squared

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Maximum tolerated dose of docetaxel

Time frame: 28 days

Data from ClinicalTrials.gov

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