Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy Clinical research trials and Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy. Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy clinical trial. Participants typically obtain the most effective healthcare available for their Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

Home > "D" Clinical Trials Conditions > Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy

Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy



Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy

For Condition: unspecified adult solid tumor, protocol specific,Anemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Darbepoetin alfa may stimulate red blood cell production and may be effective in treating anemia in patients who are receiving chemotherapy. PURPOSE: Randomized phase II trial to determine the effectiveness of darbepoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
Details: OBJECTIVES: I. Compare the efficacy of darbepotein alfa administered on the same day as chemotherapy vs an alternate time to chemotherapy administration for the treatment of anemia in patients with nonmyeloid malignancies receiving multiple courses of chemotherapy. II. Determine the safety of this drug in these patients. III. Determine the pharmacokinetic profile of this drug in these patients. PROTOCOL OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin (less than 10.0 g/dL vs 10.0-11.0 g/dL) and participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive darbepoetin alfa subcutaneously (SC) on day 15 of each chemotherapy course. Arm II: Patients receive darbepoetin alfa SC on day 1 of each chemotherapy course. In both arms, treatment repeats every 3 weeks for up to 5 courses in the absence of unacceptable toxicity or treatment failure. PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study within 8 months.
Eligibility:
Study Type:  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of a nonmyeloid malignancy Cancer- or chemotherapy-related anemia - Hemoglobin 9.0-11.0 g/dL Currently receiving chemotherapy on a 3-week course schedule - Myelosuppressive chemotherapy must not be administered on course days 9-21 - At least 2 additional courses of chemotherapy planned No other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia) --Prior/Concurrent Therapy-- Biologic therapy: - At least 4 weeks since prior epoetin alfa or darbepoetin alfa - No other concurrent epoetin alfas Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: Not specified Other: - At least 30 days since prior investigational drugs or devices - No prior enrollment on this study - No other concurrent investigational drugs - No more than 2 red blood cell (RBC) transfusions within the past 4 weeks - No RBC transfusions during the chemotherapy course before randomization --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN Cardiovascular: - No uncontrolled angina - No congestive heart failure - No New York Heart Association class III-IV cardiac disease - No uncontrolled hypertension - No cardiac arrhythmia - No other unstable or uncontrolled cardiac disease or condition Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No seizure disorder - No clinically significant inflammatory disease - No hypersensitivity to recombinant mammalian-derived products
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JohnGlaspy,  Study Chair,  Jonsson Comprehensive Cancer Center


Additional Information:
Study ID Numbers:  CDR0000069366;  NCI-G02-2071,AMGEN-20010162,UCLA-0111006
Study Start Date: 
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039247

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. RO0503821 Treatment for Correction of Anemia in Chronic Kidney Disease Patients

2. Radiation Therapy With or Without Epoetin alfa in Anemic Patients With Head and Neck Cancer

3. Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

4. Anemia in Patients with a Non-Myeloid Malignancy

5. Heart Failure and Anemia

Related Studies:

Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Clinical Trials
Other Clinical Trials

Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy
Modify your Search

  Other unspecified adult solid tumor, protocol specific Clinical Trials
  Other Clinical Trials
  Other Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103