|
Thalidomide and Docetaxel in Treating Patients With Advanced Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Thalidomide and Docetaxel in Treating Patients With Advanced Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Thalidomide and Docetaxel in Treating Patients With Advanced Cancer Clinical research trials and Thalidomide and Docetaxel in Treating Patients With Advanced Cancer healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Thalidomide and Docetaxel in Treating Patients With Advanced Cancer. Thalidomide and Docetaxel in Treating Patients With Advanced Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Thalidomide and Docetaxel in Treating Patients With Advanced Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Thalidomide and Docetaxel in Treating Patients With Advanced Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Thalidomide and Docetaxel in Treating Patients With Advanced Cancer  Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
For Condition: Cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with docetaxel may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in treating patients who have advanced cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma. - Determine the dose-limiting toxicity and safety profile of this regimen in these patients. - Determine the plasma pharmacokinetics of this regimen in these patients. - Determine the objective tumor response and prolonged freedom from progression in patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive oral thalidomide twice daily and docetaxel IV over 30 minutes once weekly. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignancy not amenable to curative surgery, radiotherapy, or chemotherapy - Tumor types may include any of the following: - Any solid tumor including, but not limited to, head and neck, breast, lung, gastrointestinal, genitourinary, melanoma, and sarcoma - Primary CNS neoplasms if the following are true: - Received primary radiotherapy - No concurrent corticosteroids or has been on a stable corticosteroid dose for at least 30 days - No concurrent enzyme-inducible anti-epileptic medications (i.e., carbamazepine or phenytoin) - Multiple myeloma - Non-Hodgkin's lymphoma - No refractory or relapsed acute or chronic leukemia - Measurable or evaluable disease - No life-prolonging therapy available - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Male or female Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - At least 4 months Hematopoietic - WBC at least 4,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST and/or ALT no greater than 2.5 times ULN if alkaline phosphatase less than ULN OR - Alkaline phosphatase no greater than 4 times ULN if AST/ALT less than ULN Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular - No New York Heart Association class III or IV heart disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and 4 weeks after study - Willing and able to comply with FDA-mandated STEPS program - No peripheral neuropathy grade 2 or greater - No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No more than 2 prior courses of mitomycin Endocrine therapy - See Disease Characteristics Radiotherapy - At least 4 weeks since prior large-field radiotherapy and recovered Surgery - Not specified Other - At least 3 weeks since other prior anticancer therapy and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScotRemick, Study Chair, University Hospitals of Cleveland
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Scot Remick 216-844-1196
Additional Information:
Study ID Numbers: CDR0000258044; NCI-G02-2123,CWRU-4Y01
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049296
Other Cancer Studies:
1. Screening Patients for NCI Protocol Eligibility
2. Biomarkers of Benzene Exposure in Inner City Residents
3. Combination Therapy of Interleukin-12 and Interleukin-2 to Treat Advanced Cancer
4. Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer
5. Treatment of Anemic Patients with Cancer who are not Receiving Chemotherapy or Radiotherapy
Related Studies:
Other Cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
|
|
|
|
|
|
|
|
