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Home > "C" Clinical Trials Conditions > Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer  Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
For Condition: cervical adenocarcinoma,cervical squamous cell carcinoma,recurrent cervical cancer,cervical adenosquamous cell carcinoma,stage 4B cervical cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI),Eastern Cooperative Oncology Group
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of three different chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical cancer.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HarryLong, Study Chair, Mayo Clinic Cancer Center
San Juan City Hospital *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68128-4157
United States
Recruiting James Mailliard 402-593-3000
Iowa Lutheran Hospital *Recruiting*
Des Moines, Iowa, 50316-2301
United States
Recruiting Roscoe Morton 515-663-5612
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Richard Kefford 61-2-9845-6033
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Higinia Cardenes 317-274-2524
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-241-4245
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
Additional Information:
Study ID Numbers: CDR0000067138; GOG-0179,ECOG-G0179
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003945
Other Recurrent Cervical Cancer Studies:
1. Cisplatin Combined with Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
2. Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
3. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
4. Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
5. Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
Related Studies:
Other recurrent cervical cancer Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
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