Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Temporarily closed 18 and over Other, Pharmaceutical / Industry SCCC-2002058 SCCC-20050719, SCCC-02/358C, SCCC-20020358, AVENTIS-SCCC-2002058, SCCC2002058, NCT00452920

Objectives

Primary

1. Determine the recommended phase II dose (RPTD) of docetaxel when administered with radiotherapy in patients with stage IIB-IVA cervical cancer. (Phase I)
2. Assess the progression-free survival of patients treated with this regimen. (Phase II)

Secondary

1. Determine the safety, feasibility, and toxicity of this regimen in these patients. (Phase I)
2. Assess the toxicity of this regimen at the RPTD in these patients. (Phase II)
3. Determine the response in patients treated with this regimen. (Phase II)

Entry 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

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

Patient Characteristics:

• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL
• WBC ≥ 3,000/mm³
• 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

Expected Enrollment

A total of 72 patients will be accrued for this study.

Outcomes

Recommended phase II dose (Phase I)
Progression-free survival (Phase II)

Response (Phase II)
Toxicity (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.

Trial Contact Information

Trial Lead Organizations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Joseph Lucci, MD, Protocol chair		Ph: 305-2430-2233

Registry Information
Official Title		A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)
Trial Start Date		2003-09-22
Trial Completion Date		2010-09-22 (estimated)
Registered in ClinicalTrials.gov		NCT00452920
Date Submitted to PDQ		2007-02-16
Information Last Verified		2008-03-30