|
Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer Clinical research trials and Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer. Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer  Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of atrasentan in treating patients who have locallyrecurrent or metastaticrenal cell (kidney) cancer.
Details: OBJECTIVES: - Determine the 6-month progression-free survival rate, in terms of proportion of those with measurable disease vs bone metastases only, of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan. - Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone metastases only). Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 180 patients (90 per stratum [with or without prior therapy]; 45 in each stratum with measurable disease and 45 with bone metastases only) will be accrued for this study within 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed locally recurrent or metastatic renal cell carcinoma that is not amenable to resection - Progressive disease, defined by 1 of the following: - At least a 20% increase in the sum of the longest diameters of the target lesions (taking as a reference the smallest sum of the longest diameters recorded since the baseline measurements) - The appearance of 1 or more new lesions - One of the following disease characteristics: - At least 1 measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Disease manifested solely by bone metastases - No prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 2,000/mm OR - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin less than 1.5 mg/dL - AST and/or ALT less than 1.5 times upper limit of normal (ULN) Renal: - Creatinine less than 1.5 times ULN Cardiovascular: - No history of New York Heart Association class II-IV heart disease Pulmonary: - No significant pulmonary disease requiring pulse steroid therapy within the past 3 months Other: - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No other serious concurrent medical illness that would preclude study participation - No active infection - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy/immunotherapy and recovered - No more than 1 prior regimen* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination) - Prior sargramostim (GM-CSF) is not counted as prior biological therapy NOTE: *A regimen is considered to be at least 4 weeks of treatment Chemotherapy: - No prior chemotherapy Endocrine therapy: - At least 4 weeks since prior hormonal agents (e.g., megestrol or tamoxifen) and recovered Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - Prior radiotherapy for local control or palliation of painful bony lesion allowed - No prior radiotherapy to target lesions - No concurrent radiotherapy for palliation or any other indication Surgery: - At least 4 weeks since prior surgery and recovered - Prior nephrectomy allowed Other: - Prior bisphosphonates allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelCarducci, Study Chair, Sidney Kimmel Cancer Center
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Carla Falkson 205-975-2691
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Porter Adventist Hospital *Recruiting*
Denver, Colorado, 80210
United States
Recruiting David Trevarthen 303-788-8675
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
St. Joseph Hospital *Recruiting*
Denver, Colorado, 80218-1191
United States
Recruiting Michael McLaughlin 303-861-3302
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Swedish Medical Center *Recruiting*
Englewood, Colorado, 80110
United States
Recruiting Marshall Davis 303-788-5860
Penrose Cancer Center *Recruiting*
Colorado Springs, Colorado, 80933
United States
Recruiting Robert Sayre 719-577-2555
Medical Center of Aurora - South Campus *Recruiting*
Aurora, Colorado, 80012-0000
United States
Recruiting Sami Diab 303-418-7600
Rocky Mountain Cancer Centers - Rose *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Scot Sedlacek 303-321-0302
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Presbyterian-St Luke's Medical Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Robert Jotte 303-388-4876
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Longmont United Hospital *Recruiting*
Longmont, Colorado, 80501
United States
Recruiting Robert Fisher 303-485-4132
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Sky Ridge Medical Center *Recruiting*
Lone Tree, Colorado, 80124
United States
Recruiting Dennis Carter 720-225-4211
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
St. Mary-Corwin Regional Medical Center *Recruiting*
Pueblo, Colorado, 81004
United States
Recruiting Marlow Sloan 719-560-6000
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 800-456-7121
Boulder Community Hospital *Recruiting*
Boulder, Colorado, 80301-9019
United States
Recruiting John Fleagle 303-440-2399
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Michael Carducci 410-502-9746
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Rocky Mountain Cancer Centers *Recruiting*
Thornton, Colorado, 80260
United States
Recruiting Alvin Otsuka 303-386-7622
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Additional Information:
Study ID Numbers: CDR0000069382; ECOG-E6800
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039429
Other Recurrent Renal Cell Cancer Studies:
1. Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
2. Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
3. Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
4. Erlotinib in Treating Patients With Advanced Kidney Cancer
5. Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other Wisconsin Clinical Trials
Other Green Bay Clinical Trials
Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
|
|
|
|
|
|
|
|
