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Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix

Phase 3
Not Enrolling
Cervical Cancer

Thank you

Trial Information

Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix


- Compare the overall survival, progression-free survival, and objective response rate
(confirmed and unconfirmed, complete and partial) of patients with recurrent,
persistent, or metastatic cervical cancer treated with cisplatin and paclitaxel vs
cisplatin and gemcitabine.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease status at study entry (metastatic vs recurrent vs persistent), prior cisplatin as a
radiosensitizer (yes vs no), and extent of disease (confined to pelvis vs extrapelvic
disease). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 2
hours on day 2.

- Arm II:Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV
over 2 hours on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this
study within 4 years.

Inclusion Criteria


- Diagnosis of primary carcinoma of the cervix, meeting 1 of the following staging

- Metastatic (stage IVB)

- Recurrent after prior complete response to primary treatment with surgery or

- Persistent after surgery or radiotherapy

- Measurable disease



- Not specified

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Not specified


- Not specified


- Creatinine less than upper limit of normal OR

- Creatinine clearance greater than 40 mL/min


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No grade 2 or greater sensory or motor neuropathy

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission


Biologic therapy

- Not specified


- More than 6 months since prior single-agent chemotherapy as a radiosensitizer

Endocrine therapy

- Not specified


- See Disease Characteristics

- At least 28 days since prior radiotherapy

- No prior radiotherapy to measurable target lesions

- No concurrent palliative radiotherapy


- See Disease Characteristics

- Recovered from prior surgery


- No prior systemic therapy

- No other concurrent antitumor therapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Harry J. Long, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 2003

Completion Date:

July 2003

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • Uterine Cervical Neoplasms



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Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
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Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
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CCOP - Virginia Mason Research Center Seattle, Washington  98101
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Eastern Virginia Medical School Norfolk, Virginia  23507
University of California Davis Cancer Center Sacramento, California  95817
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
City of Hope Comprehensive Cancer Center Duarte, California  91010
Oregon Cancer Institute Portland, Oregon  97201-3098
University of Tennessee Cancer Institute Memphis, Tennessee  38103
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