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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.)

Official Title
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A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: topotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma