Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix

Study Overview
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Brief Summary
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The purpose of this study is to find out how effectively cervix cancer is controlled when radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere, once per week, with radiation is a new treatment for cervical cancer. This study will also see how well this treatment regimen can be tolerated.

Official Title
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A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix

Conditions
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Cervix Neoplasm

Intervention / Treatment
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* Drug: docetaxel
* Procedure: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic confirmation of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix including FIGO (International Federation of Gynecologists and Obstetricians) stage IB to IVA with or without pelvic adenopathy. No evidence of para-aortic or distant metastases. Must have evaluable disease. Zubrod Performance Status 0-2 or Karnofsky Performance Status > 60 Laboratory values must be as follows: White blood cell count: > 3,000/mm3,Absolute granulocyte count: > 1,500/mm3, Hemoglobin > 8.0 g/dl, Platelets: > 100,000/mm3, Serum creatinine: < 2.5 mg/dl, Serum calcium: < 1.3 x institutional upper normal limit,Hepatic criteria as follows: Total Bilirubin < ULN for the institution, Signed study-specific informed consent p Age > 18 years. Peripheral neuropathy must be < grade 1. Exclusion Criteria: Prior or simultaneous malignancies (other than skin cancer) unless disease-free Medical illness preventing the use of taxane-based chemotherapy. Carcinoma of the cervix with the following histology: melanoma, sarcoma, small carcinoid, glassy cell, clear cell, and adenoid cystic. Previous or current medical or psychiatric illness that would prevent informed consent Patients known to be infected with HIV or a history of AIDS are excluded. Prior surgery for carcinoma of the cervix other than a biopsy. Patients with para-aortic disease. Previous pelvic radiation therapy or systemic chemotherapy is not permitted. Women who are pregnant or breast-feeding are excluded from this study. Previous history of hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 must be excluded.

Ages Eligible for Study
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Minimum Age: 18 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: docetaxel|nan|
|Procedure: Radiation Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |