S0227 Cisplatin With Either Paclitaxel or Gemcitabine in Recurrent, Persistent, or Metastatic Cervical Cancer

Launched by SWOG CANCER RESEARCH NETWORK · Apr 8, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* 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 pelvi...

Gender

FEMALE

Eligibility criteria

• DISEASE CHARACTERISTICS:
• * Diagnosis of primary carcinoma of the cervix, meeting 1 of the following staging criteria:
• • Metastatic (stage IVB)
• • Recurrent after prior complete response to primary treatment with surgery or radiotherapy
• • Persistent after surgery or radiotherapy
• • Measurable disease
• PATIENT CHARACTERISTICS:
• • Age
• • Not specified
• • Performance status
• • Zubrod 0-1
• • Life expectancy
• • Not specified
• • Hematopoietic
• • Not specified
• • Hepatic
• • Not specified
• • Renal
• • Creatinine less than upper limit of normal OR
• • Creatinine clearance greater than 40 mL/min
• • Other
• • 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
• PRIOR CONCURRENT THERAPY:
• • Biologic therapy
• • Not specified
• • Chemotherapy
• • More than 6 months since prior single-agent chemotherapy as a radiosensitizer
• • Endocrine therapy
• • Not specified
• • Radiotherapy
• • See Disease Characteristics
• • At least 28 days since prior radiotherapy
• • No prior radiotherapy to measurable target lesions
• • No concurrent palliative radiotherapy
• • Surgery
• • See Disease Characteristics
• • Recovered from prior surgery
• • Other
• • No prior systemic therapy
• • No other concurrent antitumor therapy