Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

• Status: Completed
• Trial end date: 1969-12-31
• 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 which chemotherapy regimen is more effective for cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three different chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical cancer.

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

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
• Treatments: Cisplatin; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IVB, recurrent, or persistent carcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiotherapy

• Eligible subtypes:

• Squamous cell carcinoma

• Adenosquamous carcinoma

• Adenocarcinoma

• Measurable disease by physical examination, radiography, CT scan, or MRI

• Measurable disease by CT scan/MRI without biopsy confirmation allowed if lesions are at least 3 cm and well defined

• No craniospinal metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

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

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

Hepatic:

• Bilirubin no greater than 1.5 times normal

• SGOT no greater than 3 times normal

• Alkaline phosphatase no greater than 3 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL

• No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No clinically significant infection

• No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer

• Body surface area no greater than 2.0 m^2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 6 weeks since prior chemoradiotherapy and recovered

• No prior chemotherapy except when used concurrently with radiotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• See Chemotherapy

• At least 3 weeks since prior radiotherapy only and recovered

Surgery:

• Recovered from prior surgery

Other:

• No prior anticancer treatment that would preclude study therapy