Status:
WITHDRAWN
Docetaxel and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
Lead Sponsor:
University of Miami
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy use...
Detailed Description
OBJECTIVES: Primary * Determine the recommended phase II dose (RPTD) of docetaxel when administered with radiotherapy in patients with stage IIB-IVA cervical cancer. (Phase I) * Assess the progressi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed squamous cell carcinoma of the uterine cervix
- Locally advanced (stage IIB- IVA) disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 8.0 g/dL
- WBC ≥ 3,000/mm\^3
- Creatinine normal
- Bilirubin normal
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) ≤ ULN OR AP ≤ 4 times ULN if SGOT and SGPT ≤ ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment
- No history of severe allergic reactions to agents containing polysorbate 80
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would preclude compliance with study requirements
- No peripheral neuropathy ≥ grade 2
- No HIV positivity
- PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior unrelated therapy and recovered
- No prior chemotherapy or pelvic radiotherapy
- No other concurrent investigational agents or anticancer agents or therapies
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00452920
Start Date
September 1 2003
End Date
June 1 2009
Last Update
December 15 2016
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136