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A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix

Phase 3
18 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix


- Compare the survival and response of patients with stage IVB, recurrent, or persistent
carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and
cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.

- Compare the toxic effects of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4
treatment arms.

- Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4
hours on day 2.

- Arm II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin
IV over 1-4 hours on day 1.

- Arm III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and
cisplatin as in arm II.

- Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in
arm II.

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

Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this
study within 4 years.

Inclusion Criteria


- Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or
adenocarcinoma of the cervix

- Stage IVB, recurrent, or persistent disease

- Not amenable to curative surgery and/or radiotherapy

- At least 1 unidimensionally measurable lesion

- At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by
spiral CT scan

- Biopsy confirmation required if lesion is less than 30 mm

- Target lesion must be outside of a previously irradiated field

- No craniospinal metastases



- 18 and over

Performance status

- GOG 0-1

Life expectancy

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times normal

- Alkaline phosphatase no greater than 3 times normal

- AST no greater than 3 times normal


- Creatinine ≤ 1.2 mg/dL OR

- Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min

- No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No prior or concurrent malignancy within the past 5 years except nonmelanoma skin

- No prior malignancy whose treatment contraindicates the current study therapy

- No concurrent clinically significant infection


Biologic therapy

- No concurrent cytokines


- At least 6 weeks since prior chemoradiotherapy and recovered

- No prior chemotherapy (except when concurrently administered with radiotherapy)

Endocrine therapy

- Not specified


- See Disease Characteristics

- See Chemotherapy

- At least 3 weeks since prior radiotherapy and recovered


- Recovered from prior surgery

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale at baseline, courses 2 and 5, and 9 months after completion of study treatment

Safety Issue:


Principal Investigator

Bradley J. Monk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2003

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • Uterine Cervical Neoplasms



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