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Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix Clinical research trials and Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix. Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix clinical trial. Human subjects frequently get the finest healthcare available for their Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix  Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
For Condition: recurrent cervical cancer,cervical squamous cell carcinoma
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of bevacizumab in treating patients who have persistent or recurrent cancer of the cervix.
Details: OBJECTIVES: - Determine the cytostatic antitumor activity of bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with persistent or recurrent squamous cell carcinoma of the cervix. - Determine the nature and degree of toxicity of this drug in these patients. - Estimate the distribution of PFS and overall survival for patients treated with this drug. - Determine the frequency of clinical response (partial and complete) in patients treated with this drug. - Determine the role of age and initial performance status as prognostic factors in patients treated with this drug. - Determine whether biological and imaging markers are associated with clinical efficacy of this drug, such as 6-month PFS, in these patients. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-38 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed persistent or recurrent squamous cell carcinoma (SCC) of the cervix - Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix - Chemotherapy administered as a radio-sensitizer does not count as 1 regimen - Documented disease progression - At least 1 unidimensionally measurable lesion* - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Tumors within a previously irradiated field are considered nontarget lesions unless documented evidence of progressive disease or biopsy-confirmed persistent disease at least 90 days after completion of radiotherapy - No history or physical evidence of CNS disease, including primary or metastatic brain tumor - Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active GOG phase III protocol for the same patient population PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - GOG 0-2 (if received 1 prior regimen) - GOG 0-1 (if received 2 prior regimens) Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No known bleeding disorder or coagulopathy Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN - INR less than 1.5 - PTT less than 1.2 times control Renal: - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance greater than 60 mL/min - No proteinuria - Urine protein less than 30 mg/dL OR - Urine protein less than 500 mg by 24-hour urine collection Cardiovascular: - No clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina) - No New York Heart Association grade II or greater congestive heart failure - No serious cardiac arrhythmia requiring medication - No history of deep vein thrombosis - No grade II or greater peripheral vascular disease within the past year - No history of stroke Other: - No greater than grade 1 sensory or motor neuropathy - No active infection requiring antibiotics - No serious nonhealing wound, ulcer, or bone fracture - No history or physical evidence of seizures not controlled with standard medical therapy - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies - No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer - No significant traumatic injury within the past 4 weeks - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bevacizumab - At least 3 weeks since prior immunologic agents for SCC of the cervix Chemotherapy: - See Disease Characteristics - Recovered from prior chemotherapy - No prior non-cytotoxic chemotherapy for persistent or recurrent disease Endocrine therapy: - At least 1 week since prior hormonal therapy for SCC of the cervix - Concurrent hormone replacement therapy allowed Radiotherapy: - See Disease Characteristics - Recovered from prior radiotherapy Surgery: - Recovered from recent prior surgery - At least 4 weeks since prior major surgical procedure or open biopsy - At least 1 week since prior placement of vascular access device - No concurrent major surgical procedure Other: - At least 3 weeks since other prior therapy for SCC of the cervix - No prior anticancer therapy that would preclude study therapy - No concurrent anticoagulants other than those required to maintain the patency of indwelling IV catheters - No concurrent chronic daily aspirin greater than 325 mg/day or other nonsteroidal anti-inflammatory medications that are known to inhibit platelet function at doses used for chronic inflammatory diseases
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BradleyMonk, Study Chair, Chao Family Comprehensive Cancer Center
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Joseph Kelley 412-641-5418
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville, Tennessee, 37917
United States
Recruiting Kenneth Cofer 865-673-9250
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Daniel Clarke-Pearson 919-684-3765
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Gunnar Kristensen 47-22-934-000
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting Michael Method 574-237-8010
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62794-9640
United States
Recruiting L. Massad 217-545-8882
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0587
United States
Recruiting Edward Hannigan 409-772-3368
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Marta Crispens 615-322-2114
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Nava Siegelmann-Danieli 570-271-6834
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000068940; GOG-0227C
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025233
Other Cervical Squamous Cell Carcinoma Studies:
1. Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer
2. Erlotinib in Treating Patients With Persistent or Recurrent Cancer of the Cervix
3. SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
4. Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix
5. Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
Related Studies:
Other cervical squamous cell carcinoma Clinical Trials
Other Tennessee Clinical Trials
Other Knoxville Clinical Trials
Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
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