NCT00178269CompletedPhase 2
A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Rochester
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Investigators
Study Sites (1)
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