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

• Status: Withdrawn
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin is more effective when combined with paclitaxel or gemcitabine in treating cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with paclitaxel to that of cisplatin combined with gemcitabine in treating women who have recurrent, persistent, or metastatic cervical cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine; Paclitaxel

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