Expired Study
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Rochester, New York 14642


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.


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.


Study is Available At:


Original ID:

URCC 1328


NCT ID:

NCT00178269


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Rochester


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Yuhchyau Chen, MD, Ph.D
Principal Investigator
Universtiy of Rochester, Dept of Radiation Oncology

Study Dates

Start Date:January 2005
Primary Completion Date:June 2006
Primary Completion Type:Actual
Verification Date:May 2009
Last Changed Date:May 15, 2009
First Received Date:September 12, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:docetaxel
Intervention Type:Procedure
Name:Radiation Therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Rochester

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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