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

Primary Purpose

Cervix Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
Radiation Therapy
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervix Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Rochester, Dept. Radiation Oncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
May 15, 2009
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00178269
Brief Title
Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
Official Title
A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuhchyau Chen, MD, Ph.D
Organizational Affiliation
Universtiy of Rochester, Dept of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester, Dept. Radiation Oncology
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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