A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
- 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
- Signed study-specific informed consent p
- Age > 18 years.
- Peripheral neuropathy must be < grade 1.
- 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
- 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.