Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Docetaxel

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.