A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)
18 Years
N/A
Female
Cervical Cancer
Trial Information
A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)
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 progression-free survival of patients treated with this regimen. (Phase II)
Secondary
- Determine the safety, feasibility, and toxicity of this regimen in these patients.
(Phase I)
- Assess the toxicity of this regimen at the RPTD in these patients. (Phase II)
- Determine the response in patients treated with this regimen. (Phase II)
OUTLINE: This is a phase I, nonrandomized, prospective, dose-escalation study of docetaxel
followed by an open-label phase II study.
- Phase I: Patients receive docetaxel IV over 30 minutes on day 1. Treatment repeats
weekly for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients also undergo concurrent pelvic external-beam radiotherapy (EBRT)
once daily 5 days a week for 5 weeks. Beginning 1-2 weeks after completion of EBRT,
patients receive one or two applications of intracavitary low-dose-rate brachytherapy
(LDR BT) comprising cesium-137.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RPTD) is the
dose below the MTD.
- Phase II: Patients receive docetaxel at the RPTD, EBRT, and LDR BT as in phase I.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recommended phase II dose (Phase I)
Safety Issue:
Yes
Principal Investigator
Joseph A. Lucci, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Miami Sylvester Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
EPROST-20020358
NCT ID:
NCT00452920
Start Date:
September 2003
Completion Date:
June 2009
Related Keywords:
- Cervical Cancer
- cervical squamous cell carcinoma
- stage IIB cervical cancer
- stage III cervical cancer
- stage IVA cervical cancer
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
