Status:
COMPLETED
Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
Lead Sponsor:
University of Rochester
Conditions:
Cervix Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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, wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00178269
Start Date
January 1 2005
Last Update
May 19 2009
Active Locations (1)
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1
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642