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

Cervix Neoplasm Clinical Trial

Official title:

A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178269
• Other study ID #: URCC 1328
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 15, 2009
• Start date: January 2005

Study information

• Verified date: May 2009
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervix Neoplasm
• Uterine Cervical Neoplasms

Intervention

Drug:
• docetaxel

Procedure:
• Radiation Therapy

Locations

Country	Name	City	State
United States	University of Rochester, Dept. Radiation Oncology	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States,