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

This study is ongoing, but not recruiting participants.

Sponsored by: University of Rochester
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00178269
  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 II

MedlinePlus related topics:   Cancer    Cervical Cancer   

ChemIDplus related topics:   Docetaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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


Study ID Numbers:   URCC 1328
First Received:   September 12, 2005
Last Updated:   September 6, 2006
ClinicalTrials.gov Identifier:   NCT00178269
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Docetaxel
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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