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A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)

Phase 1/Phase 2
18 Years
Not Enrolling
Cervical Cancer

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Trial Information

A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)



- 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)


- 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


- Histologically or cytologically confirmed squamous cell carcinoma of the uterine

- 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


- 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

- 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


- 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:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase II dose (Phase I)

Safety Issue:


Principal Investigator

Joseph A. Lucci, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




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



University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136