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

University of Rochester

Status and phase: Completed; Phase 2

Conditions: Cervix Neoplasm

Treatments: Drug: docetaxel; Procedure: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00178269

URCC 1328

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)