Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma
N/A
N/A
Female
Cervical Cancer
Trial Information
Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma
OBJECTIVES: I. Assess the antitumor activity of docetaxel as neoadjuvant chemotherapy in
patients with locally advanced squamous cell carcinoma of the cervix. II. Assess the tumor
response, toxic effect, and survival rate of this regimen in these patients.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Treatment is repeated every 3
weeks for 3 courses. Patients are followed every 3 months posttreatment.
PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven stage IIB, IIIA, IIIB, and IVA squamous
cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis
PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3
Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of
normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine
less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other
concurrent malignancies, other than properly treated basal cell skin cancer
PRIOR CONCURRENT THERAPY: Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Carlos Teodoro Vallejo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Grupo Oncologico Cooperativo del Sur
Authority:
United States: Federal Government
Study ID:
GOCS-04-CC-97
NCT ID:
NCT00003445
Start Date:
December 1997
Completion Date:
April 2004
Related Keywords:
- Cervical Cancer
- stage III cervical cancer
- stage IIB cervical cancer
- stage IVA cervical cancer
- cervical squamous cell carcinoma
- Uterine Cervical Neoplasms
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