Docetaxel and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer - Full Text View

Sponsored by:	University of Miami Sylvester Comprehensive Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00452920

Purpose

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 uses high-energy x-rays and other types of radiation to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients with stage II, stage III, or stage IV cervical cancer.

Condition	Intervention	Phase
Cervical Cancer	Drug: docetaxel Radiation: cesium Cs 137 Radiation: radiation therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Recommended phase II dose (Phase I) [ Designated as safety issue: Yes ]
Progression-free survival (Phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response (Phase II) [ Designated as safety issue: No ]
Toxicity (Phase II) [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	September 2003
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452920

Locations

United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami Sylvester Comprehensive Cancer Center

Investigators

Study Chair:

Joseph A. Lucci, MD

University of Miami Sylvester Comprehensive Cancer Center - Miami

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Miami Sylvester Comprehensive Cancer Center - Miami ( Joseph A. Lucci, III )
Study ID Numbers:	CDR0000537506, EPROST-20020358, SCCC-20050719, SCCC-02/358C, SCCC-20020358, AVENTIS-SCCC-2002058
Study First Received:	March 27, 2007
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00452920 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cervical squamous cell carcinoma
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer

Study placed in the following topic categories:

Docetaxel
Radiation-Sensitizing Agents
Epidermoid Carcinoma

Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:

Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009