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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178269
First Posted: September 15, 2005
Last Update Posted: May 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Rochester
  Purpose
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.

Condition Intervention Phase
Cervix Neoplasm Drug: docetaxel Procedure: Radiation Therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Study Start Date: January 2005
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178269


Locations
United States, New York
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Yuhchyau Chen, MD, Ph.D Universtiy of Rochester, Dept of Radiation Oncology
  More Information

Responsible Party: Yuhchyau Chen, MD,Ph.D, University of Rochester. Medical Center
ClinicalTrials.gov Identifier: NCT00178269     History of Changes
Other Study ID Numbers: URCC 1328
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: May 19, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action