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OpenTrials
Completed

NCT Number: NCT00178269

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester, Dept. Radiation Oncology

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

Radiation Therapy

Procedure

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
First posted
Sep 15, 2005
Registry last updated
May 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.