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


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervix Neoplasm

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Yuhchyau Chen, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universtiy of Rochester, Dept of Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

URCC 1328

NCT ID:

NCT00178269

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Cervix Neoplasm
  • Neoplasms
  • Carcinoma
  • Uterine Cervical Neoplasms

Name

Location

University of Rochester, Dept. Radiation OncologyRochester, New York  14642