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Home > "T" Clinical Trials Conditions > Treatment of Prostate Cancer with Docetaxel Alone and in Combination with Thalidomide  Treatment of Prostate Cancer with Docetaxel Alone and in Combination with Thalidomide
Treatment of Prostate Cancer with Docetaxel Alone and in Combination with Thalidomide
For Condition: Prostatic Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will compare the safety and effectiveness of the drug docetaxel given alone and in combination with another drug, thalidomide, for treating prostate cancer. An approved anti-cancer drug, docetaxel has helped some patients with prostate cancer. Thalidomide, approved to treat leprosy, lessened pain and lowered PSA (a protein that is elevated in prostate cancer) blood levels in some patients who took the drug in a previous NCI prostate cancer study. Men with advanced prostate cancer that does not respond to hormonal therapy may be eligible for this study. Candidates will undergo various screening tests that may include CT scans and blood and urine tests. Patients admitted to the study will be randomly assigned to treatment with either docetaxel alone or docetaxel and thalidomide. At the start of the study, patients in the docetaxel alone treatment group will be given one dose of docetaxel infused through a vein (intravenously, or IV) over a 30-minute period. Blood samples will be taken the next day to determine the amount of drug in the blood. Those in the docetaxel plus thalidomide group will receive one dose of thalidomide followed by 1 day of blood sampling. About a week later, they will receive a dose of docetaxel followed by 1 day of blood sampling. All patients will take a diuretic before and after the docetaxel infusion to prevent possible fluid retention caused by the drug. After the initial drug doses, all patients will receive docetaxel IV once a week for 3 consecutive weeks out of 4 (in 28-day cycles) and patients in the thalidomide group will also take one thalidomide pill daily. The response to therapy will be evaluated every 2 to 3 months using various tests, such as bone and CT scans. If there are no severe side effects and the cancer has not progressed, treatment may continue for more than 6 months. Blood will be drawn monthly to measure drug concentration in the body and to examine other factors associated with the cancer. A prostate biopsy will be done before treatment begins and again about 2 or more months after treatment starts to evaluate drug effects on the tumor cells and blood vessel growth
Details: Thalidomide and docetaxel have both shown biologic activity against androgen independent prostate cancer (AIPC). This is a randomized phase II study designed to evaluate the efficacy of weekly docetaxel as compared to the combination of docetaxel and thalidomide in patients with AIPC. Patients will receive repeated 28-day cycles of docetaxel, comprising weekly treatments for three consecutive weeks followed by one week off or the combination of daily thalidomide and docetaxel administered at the same schedule described above. Each patient that has biopsiable lesions will undergo a pretreatment biopsy of their prostate (or other site of soft tissue disease). This will be repeated after 2 months in patients who are receiving docetaxel alone and after two months in those who receive the combination arm. Molecular markers of apoptosis, angiogenesis as well as pharmacokinetics will be evaluated in all patients. All patients will undergo repeat bone scan and CT scan every two months in order to assess the efficacy of each treatment.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have androgen independent metastatic adenocarcinoma of the prostate. Patients must have histopathological documentation of prostate caner confirmed in the Pathology Department of he Clinical Center at the National Institutes of Health or the Pathology Department at the National Naval Medical Center, prior to starting this study. In addition, patients whose slides are unavailable will be eligible with documentation of prostate cancer and a clinical course consistent with the disease. Patients must have clinically progressive prostate cancer documented by prior to entry. Progression must be documented by at least one of the following parameters. Two consecutively rising PSA levels: The first rising PSA must be a minimum of one week from a reference value. It is recognized the PSA fluctuations are such that the confirmatory PSA value might be less then the previous one. In these cases the patient would still be eligible provided the next PSA was greater than the first rising PSA value. Patients must have a PSA greater than or equal to 5.0; At least one new lesion on bone scan; Progressive measurable disease. All patients who have not undergone surgical castration must have a serum testosterone under 50 ng/ml and continue on their GnRh agonist. Patients who are receiving an anti-androgen and are entering the trial due to a rise in PSA must demonstrate a continued rise in PSA 4 weeks after stopping flutamide and 6 weeks after stopping bicalutamide or nilutamide. Patients must have an ECOG performance status of 0-1. Patients must have recovered from any toxicity from surgery or radiotherapy. Patients may not have received any chemotherapy for metastatic prostate cancer. Absolute neutrophil count greater than 1,500/mm(3). Platelet count greater than or equal to 100,00/mm(3). If the creatinine is greater than 1.5 mg/dL, a 24 hour urine collection must be obtained, and measured creatinine clearance must be at least 40 mL/min. Hepatic function: Hepatic: Bilirubin less than 1.0 mg/dl, AST and ALT less than 2.5 times upper limit of normal. If the alkaline phosphatase is greater than 2.5 times the upper limit of normal, it must be fractionated and the hepatic alkaline phosphatase should be less than 2.5 times the upper limit of normal. Patients must be capable of understanding and signing an informed consent form. Patients must be willing to travel from their home to the NIH for follow-up visits. Patients must be at least 18 years of age. Patients must be able and willing to follow instructions and conform to protocol. Patients may have had no other active malignancy within the past 2 years with the exception of non-melanoma skin cancer and in-situ bladder carcinoma. Patients may have no history of myocardial infarction within the past 6 months, uncontrolled CHF, or uncontrolled angina pectoris. Patients who have not had a radical prostatectomy must agree to a biopsy of the prostate or other areas of prostatic carcinoma. EXCLUSION CRITERIA: Patients with brain metastases are ineligible. Patients who have previously received docetaxel or thalidomide are ineligible.
Total Enrollment: 75
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000033; 00-C-0033
Study Start Date: December 8, 1999
Record last reviewed: September 29, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001942
Other Prostatic Neoplasm Studies:
1. A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma
2. Treatment of Prostate Cancer with Docetaxel Alone and in Combination with Thalidomide
3. Genetic Analysis of Hereditary Prostate Cancer
4. A Phase I Trial of Continuous Infusion UCN-01 in Patients with Refractory Neoplasms
5. A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer
Related Studies:
Other Prostatic Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Treatment of Prostate Cancer with Docetaxel Alone and in Combination with Thalidomide
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