|
Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced 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 Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer Clinical research trials and Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced 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 Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer. Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced 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 Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced 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 > "E" Clinical Trials Conditions > Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer  Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
For Condition: unspecified adult solid tumor, protocol specific,Anorexia,Cachexia
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Etanercept is a substance that is being studied as a treatment for cachexia (weight loss) and anorexia (lack of appetite) in patients who have cancer. It is not yet known whether etanercept is effective in improving cancer-related cachexia and anorexia. PURPOSE: Randomizedphase III trial to determine the effectiveness of etanercept in treating cancer-related cachexia and anorexia in patients who have advanced cancer.
Details: OBJECTIVES: - Compare etanercept vs placebo in the treatment of cancer-related cachexia and anorexia, in terms of weight measurement and rate of weight change, in patients with advanced malignancies. - Assess the functional status and appetite of patients treated with this drug. - Assess the quality of life of patients treated with this drug. - Determine whether this drug prolongs survival of these patients. - Determine the toxic effects of this drug in these patients. - Determine the effect of this drug on nausea and vomiting in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to primary malignant disease (lung vs gastrointestinal vs other), severity of weight loss (less than 4.6 kg vs at least 4.6 kg), planned concurrent chemotherapy (yes vs no), age (less than 50 vs 50 and over), gender, planned use of megestrol or other progestational agent (yes vs no), and GBU Prognostic Index (good vs bad vs unsure). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive etanercept subcutaneously (SC) twice weekly. - Arm II: Patients receive placebo SC twice weekly. Treatment in both arms continues for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, weekly for 1 month, and then monthly during treatment. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A total of 274 patients (137 per treatment arm) will be accrued for this study within 19 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignancy except brain cancer - If the patient has multiple primaries or an unknown primary, the currently active cancer cannot be brain cancer - Disease considered incurable with available therapies - No clinical evidence of ascites - Weight loss of at least 5 pounds (2.3 kg) within the past 2 months (excluding perioperative weight loss) and/or estimated caloric intake of less than 20 cal/kg daily - Weight gain determined by physician to be beneficial - Patient perceives weight loss as a problem PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No poorly controlled congestive heart failure - No poorly controlled hypertension - No pacemaker, implanted defibrillator, stents, or metal suture material in the heart or great vessels (for patients participating in the BIA translational portion of the study) Gastrointestinal - No known mechanical obstruction of the alimentary tract - No malabsorption - No intractable vomiting (more than 5 episodes/week) - Not concurrently receiving tube feedings or parenteral nutrition Other - Able to reliably administer subcutaneous medication twice weekly - Alert and mentally competent - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - More than 1 month since prior infliximab - No concurrent live vaccination Chemotherapy - Concurrent chemotherapy allowed Endocrine therapy - At least 1 month since prior adrenal steroids - No concurrent adrenal steroids (inhalant, topical, or optical steroids allowed) - Concurrent short-term dexamethasone for chemotherapy-induced emesis is allowed Radiotherapy - Concurrent radiotherapy allowed Surgery - Not specified Other - More than 1 month since prior etanercept - No concurrent evaluation with another device that injects an electrical current into the body (for patients participating in the bioelectrical impendance analysis [BIA] translational portion of the study)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AminahJatoi, Study Chair, Mayo Clinic Cancer Center
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Mark Olsen 918-499-2000
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54301
United States
Recruiting Anthony Jaslowski 920-884-3135
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Muhammad Salim 306-766-2203
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Charles Loprinzi 507-284-8964
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
Additional Information:
Study ID Numbers: CDR0000257027; NCCTG-N00C1,NCI-P02-0232
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046904
Other Cachexia Studies:
1. Bizelesin in Treating Patients With Advanced Cancer
2. Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
3. Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors
4. Endostatin in Treating Patients With Advanced Solid Tumors
5. Study of Decision Making in Patients Participating in Phase I Clinical Trials
Related Studies:
Other Cachexia Clinical Trials
Other Minnesota Clinical Trials
Other Duluth Clinical Trials
Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
|
|
|
|
|
|
|
|
