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
cisplatin
+ topotecan hydrochloride
Urogenital Diseases+10
+ Genital Diseases
+ Uterine Cervical Diseases
Treatment Study
Summary
Study start date: June 1, 1999
Actual date on which the first participant was enrolled.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.)
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
Indiana University Cancer Center
Indianapolis, United StatesOpen Indiana University Cancer Center in Google MapsJohn Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, United StatesMercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, United StatesIowa Lutheran Hospital
Des Moines, United States