Cervix Neoplasm
Conditions
Brief summary
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.
Interventions
DRUGdocetaxel
PROCEDURERadiation Therapy
Sponsors
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed