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

NCT00178269 | Completed Phase 2

• 1 other identifier: URCC 1328
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix Neoplasm

Interventions

docetaxel DRUG

Radiation Therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester, Dept. Radiation Oncology

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Docetaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Study Officials

• Yuhchyau Chen, MD, Ph.D

  Universtiy of Rochester, Dept of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2006
• Last Updated: May 19, 2009

Record last verified: 2009-05

Locations

US (1)