Expired Study
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Rochester, New York 14642


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00178269


Primary Contact:

Principal Investigator
Yuhchyau Chen, MD, Ph.D
Universtiy of Rochester, Dept of Radiation Oncology


Backup Contact:

N/A


Location Contact:

Rochester, New York 14642
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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