Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

OBJECTIVES:

• Compare the response rate and survival of patients with stage IVB, recurrent, or persistent carcinoma of the cervix treated with cisplatin only vs cisplatin plus topotecan vs methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC). (Arm III (MVAC) closed to accrual effective 07/23/2001.)

• Compare the toxic effects of these regimens in this patient population.

• Compare health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to GOG performance status. Patients are randomized to one of three treatment arms. (Arm III closed to accrual effective 07/23/2001.)

• Arm I: Patients receive cisplatin IV once every 21 days.

• Arm II:Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin IV (beginning after topotecan infusion) on day 1. Courses repeat every 21 days.

• Arm III:Patients receive methotrexate IV on days 1, 15, and 22, vinblastine IV on days 2, 15, and 22, and doxorubicin IV and cisplatin IV on day 2. Courses repeat every 28 days. (Arm III closed to accrual effective 07/23/2001.) Treatment in all arms continues for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. (Arm III closed to accrual effective 07/23/2001.)

Quality of life is assessed before randomization, before course 2, before course 5 (arms I and II), before course 4 (arm III), and at 9 months. (Arm III closed to accrual effective 07/23/2001.)

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

PROJECTED ACCRUAL: A total of 400 patients (133 per treatment arm) will be accrued for this study within 2 years. (Arm III closed to accrual effective 07/23/2001.)

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

Harry J. Long

Study Chair

Higinia R. Cardenes

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003945
Information obtained from ClinicalTrials.gov on November 20, 2012

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