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Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study


Phase 1
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

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Trial Information

Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of docetaxel when administered with carboplatin in
patients with recurrent stage IVB squamous cell carcinoma of the cervix.

- Determine the response rate and time to progression in patients treated with this
regimen.

Secondary

- Determine the toxicity of this regimen in these patients.

- Determine the quality of life of patients treated with this regimen.

OUTLINE: This is phase I, dose-escalation study of docetaxel followed by a phase II study.

- Phase I: Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30
minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in
the absence of disease progression or unacceptable toxicity. Patients who demonstrate
continuing tumor shrinkage after 6 courses receive 2 additional courses beyond their
best response.

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.

- Phase II: Patients receive docetaxel and carboplatin as in phase I at the MTD
determined in phase I.

Quality of life is assessed at baseline, before every other course of treatment, and at the
end of study treatment.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 16-40 for phase II) will
be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the uterine cervix

- Advanced disease (stage IVB)

- Persistent or recurrent disease

- No available curative treatment options

- Measurable disease by physical examination, chest x-ray, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- GOG 0-2

Life expectancy

- More than 6 months

Hematopoietic

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin > 8 g/dL

Hepatic

- Bilirubin normal

- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal
OR

- Alkaline phosphatase ≤ 4 times ULN AND SGOT and SGPT normal

Renal

- Creatinine < 1.5 times ULN

Other

- No other invasive malignancy within the past 5 years

- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with
polysorbate 80

- No peripheral neuropathy > grade 1

- No other concurrent malignancy except curatively treated non-melanoma skin cancer

- No other serious medical or psychiatric illness that would preclude giving informed
consent or limit survival

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent biologic therapy

Chemotherapy

- No more than 2 prior chemotherapy regimens

- One sensitizing chemotherapy regimen during radiotherapy AND 1 regimen for
recurrent disease are considered 2 regimens

- At least 4 weeks since prior chemotherapy

- No prior docetaxel

- No prior carboplatin

- No other concurrent chemotherapy

Endocrine therapy

- At least 4 weeks since prior hormonal therapy

Radiotherapy

- See Chemotherapy

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery

- At least 3 weeks since prior major surgery

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of docetaxel

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Brigitte E. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000366942

NCT ID:

NCT00084890

Start Date:

November 2003

Completion Date:

April 2010

Related Keywords:

  • Cervical Cancer
  • stage IVB cervical cancer
  • recurrent cervical cancer
  • cervical squamous cell carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096