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Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical research trials and Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer. Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer  Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
For Condition: stage 4 ovarian epithelial cancer,peritoneal cavity cancer,recurrent ovarian epithelial cancer
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 recurrentovarian epithelial cancer or primaryperitoneal cancer.
Details: OBJECTIVES: - Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab. - Determine the nature and degree of toxicity of this drug in these patients. - Determine the progression-free and overall survival of patients treated with this drug. - Determine the frequency of clinical response in patients treated with this drug. - Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients. - Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days 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 55-62 patients will be accrued for this study within 2.2-2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial or primary peritoneal carcinoma - Recurrent or persistent after initial standard surgery or chemotherapy - Incurable with standard surgery, chemotherapy, or radiotherapy - At least 1 unidimensionally measurable target lesion - At least 20 mm by conventional techniques - At least 10 mm by spiral CT scan - Outside the area of prior radiotherapy - Accessible to guided core needle biopsy - Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease - May have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment - Patients with only 1 prior platinum-based chemotherapy regimen must have an initial treatment-free interval of less than 12 months - Patients with an initial treatment-free interval of more than 12 months must have progressive disease after prior platinum-based chemotherapy regimen as second-line therapy - No history or evidence of CNS disease (primary brain tumor or brain metastases) - Ineligible for higher priority GOG protocols (i.e., active GOG phase III protocols for the same patient population) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - GOG 0-2 (patients who have received 1 prior regimen) - GOG 0-1 (patients who have received 2 prior regimens) Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count greater than 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 - PT (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: - At least 1 year since any of the following: - Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina) - New York Heart Association class II-IV congestive heart failure - Serious cardiac arrhythmia requiring medication - History of deep vein thrombosis - Grade II or greater peripheral vascular disease - No history of stroke Other: - No significant traumatic injury within the past 28 days - No other invasive malignancy within the past 5 years except nonmelanoma skin cancer - No seizures not controlled with standard medical therapy - No grade 2 or greater neuropathy (motor and sensory) - No serious non-healing wound, ulcer, or bone fracture - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies - No active infection requiring antibiotics - No known claustrophobia that would preclude MRI tolerance - No ferromagnetic implants or pacers - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior immunologic therapy directed at malignancy - No prior bevacizumab - No other concurrent immunotherapy directed at malignancy Chemotherapy: - See Disease Characteristics - One additional prior cytotoxic regimen for recurrent or persistent disease allowed - No prior non-cytotoxic chemotherapy for recurrent or persistent disease - No concurrent chemotherapy directed at malignancy Endocrine therapy: - At least 1 week since prior hormonal therapy directed at malignancy - No concurrent hormonal therapy directed at malignancy - Concurrent hormone replacement therapy allowed Radiotherapy: - See Disease Characteristics - Recovered from prior radiotherapy - No concurrent radiotherapy directed at malignancy Surgery: - See Disease Characteristics - At least 28 days since prior major surgery or open biopsy and recovered - At least 7 days since prior placement of vascular access device - No anticipated need for major surgical procedure during study participation Other: - At least 3 weeks since other prior therapy directed at malignancy - No prior anticancer therapy that would preclude study entry - No concurrent anticoagulants except those needed to maintain patency of indwelling IV catheters - No concurrent chronic aspirin usage of more than 325 mg/day - No concurrent nonsteroidal anti-inflammatory medications known to inhibit platelet function at doses used to treat chronic inflammatory diseases
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertBurger, Study Chair, Chao Family Comprehensive Cancer Center
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting Michael Method 574-237-8010
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Willie Andersen 434-924-9333
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Marta Crispens 615-322-2114
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Nava Siegelmann-Danieli 570-271-6834
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Joseph Kelley 412-641-5418
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62794-9640
United States
Recruiting L. Massad 217-545-8882
Keesler Medical Center - Keesler Air Force Base *Recruiting*
Keesler AFB, Mississippi, 39534-2576
United States
Recruiting John Bomalaski 228-377-6396
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Bradley Monk 714-456-6570
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting David Mutch 314-362
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville, Tennessee, 37917
United States
Recruiting Kenneth Cofer 865-673-9250
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1002
United States
Recruiting Joel Sorosky 319-356-2015
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1740
United States
Recruiting Jonathan Berek 310-206-5161
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Andrew Menzin 516-562-4438
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0587
United States
Recruiting Edward Hannigan 409-772-3368
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Mack Barnes 205-934-0930
Additional Information:
Study ID Numbers: CDR0000068839; GOG-0170D
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022659
Other Stage 4 Ovarian Epithelial Cancer Studies:
1. Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
2. Tumor Vaccine and Interferon gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
3. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
4. Toremifene in Treating Patients With Ovarian Cancer
5. Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Related Studies:
Other stage 4 ovarian epithelial cancer Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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