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Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma Clinical research trials and Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma. Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma  Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma
Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma
For Condition: Renal Cell Cancer
Status: Recruiting
Sponsor(s): Genentech ,
Synopsis: The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Written informed consent - Histologically confirmed RCC of clear cell histology - Confirmed metastatic RCC - Age >=18 - ECOG performance status of 0 or 1 - Life expectancy >= 3 months - Prior nephrectomy - Measurable disease, as defined by RECIST - Use of an acceptable means of contraception (potentially fertile men and women) Exclusion Criteria: - RCC of papillary or collecting-duct type, mixed histologies, and presence of sarcomatoid features - Prior systemic or adjuvant therapy for RCC - Prior radiotherapy for RCC within 28 days prior to Day 0, with the exception of single-fraction radiotherapy given for the indication of pain control - Treatment with Avastin, Erlotinib, or other agents, either investigational or marketed, that act by either EGFR inhibition or anti-angiogenesis mechanisms - Screening clinical laboratory values: * 24-hour urine collection with >= 1 g of protein * INR >= 1.5, except for subjects receiving warfarin therapy * Serum creatinine > 2.0 mg/dL * Serum calcium > 10 mg/dL (corrected) * Absolute neutrophil count (ANC) < 1500/uL * Platelet count < 75,000/uL * Total bilirubin > 2.0 mg/dL * AST or ALT > 5x the upper limit of normal (ULN) for subjects with documented liver metatases; > 2.5 x ULN for subjects without evidence of liver metastases * LDH > 1.5 x ULN * Hemoglobin < 9 gm/dl (may be transfused or receive epoetin alfa to maintain or exceed this level - History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure > 160/110 mmHg on medication), unstable angina, New York Heart Association Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication, or Grade II or greater peripheral vascular disease - Other invasive malignancies, including bladder cancer and low-grade endometrial cancer within 5 years of randomization (other than squamous or basal cell carcinoma of the skin) - Pregnancy or breast feeding - Inability to comply with study and/or follow-up procedures - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications - Serious, non-healing wound, ulcer, or bone fracture - Evidence of bleeding diathesis or coagulopathy - History or clinical evidence of central nervous system or brain metastases - History of bowel or gastric perforation - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0
Total Enrollment: 100
Location and Contact Information:
Lynn Regional Cancer Center - West *Not yet recruiting*
Boca Raton, Florida, 33428
United States
Not yet recruiting Israel Wiznitzer 561-883-7503
Our Lady of Mercy Medical Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Janice Dutcher 718-920-9021
Northwestern Carolina Oncology & Hematology *Recruiting*
Hickory, North Carolina, 28601
United States
Recruiting Richard Orlowski 828-324-9550
Wayne State University / Harper University Hospital *Not yet recruiting*
Detroit, Michigan, 48201
United States
Not yet recruiting Ulka Vaishampayan 313-745-9423
Nevada Cancer Center *Recruiting*
Las Vegas, Nevada, 89109
United States
Recruiting Dimitrios Diamandidis 702-735-7154
UCHSC - Urologic Oncology *Not yet recruiting*
Aurora, Colorado, 80010
United States
Not yet recruiting Michael Glode 303-848-0651
Beth Israel Deaconess Medical Center *Not yet recruiting*
Boston, Massachusetts, 02215
United States
Not yet recruiting You Ko 617-667-1904
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Vincent Vinciguerra 516-562-8942
NYU School of Medicine *Recruiting*
New York City, New York, 10016
United States
Recruiting Anna Pavlick 212-263-6485
Stanford University Medical Center *Recruiting*
Stanford, California, 94305
United States
Recruiting Sandy Srinivas 650-725-1252
The Cleveland Clinic *Not yet recruiting*
Cleveland, Ohio, 44195
United States
Not yet recruiting Ronald Bukowski 216-444-7921
Fox Chase Cancer Center *Not yet recruiting*
Philadelphia, Pennsylvania, 19111
United States
Not yet recruiting Naomi Haas 215-728-5311
Wilshire Oncology Medical Group, Inc. *Recruiting*
La Verne, California, 91750
United States
Recruiting Linda Bosserman 909-596-5333
The Cancer Center at Hackensack University Medical Center *Not yet recruiting*
Hackensack, New Jersey, 07601
United States
Not yet recruiting Robert Alter 201-336-8017
Ochsner Cancer Institute *Not yet recruiting*
New Orleans, Louisiana, 70121
United States
Not yet recruiting Carl Kardinal 504-842-3708
Urology Associates, Inc. *Not yet recruiting*
Nashville, Tennessee, 37209
United States
Not yet recruiting David Bilhartz 615-250-9267
St. Joseph Oncology *Not yet recruiting*
St. Joseph, Missouri, 64507
United States
Not yet recruiting Robert Weigand 816-271-1032
University of Pennsylvania *Not yet recruiting*
Philadelphia, Pennsylvania, 19004
United States
Not yet recruiting Keith Flaherty 215-615-3345
Additional Information:
Study ID Numbers: AVF2938g;
Study Start Date: March 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081614
Other Renal Cell Cancer Studies:
1. Gene Therapy in Treating Patients With Cancer
2. Genetic Study to Identify Gene Mutations in Participants Previously Enrolled in Clinical Trial NCI-99-C-0053 Who Have von Hippel-Lindau Syndrome or Are at Risk for von Hippel-Lindau Syndrome
3. Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma
4. Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
5. Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer
Related Studies:
Other Renal Cell Cancer Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma
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