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

Phase 2

Completed

• Conditions: Cervix Neoplasm

• Registration Number: NCT00178269
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2006-06
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

University of Rochester, Dept. Radiation Oncology; 🇺🇸 Rochester, New York, United States