Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer
This trial is active, not recruiting.
|Treatments||bicalutamide, docetaxel, gnrh analog, radiotherapy|
|Sponsor||David T. Marshall|
|Start date||July 2010|
|End date||January 2011|
|Trial size||20 participants|
|Trial identifier||NCT00099086, AVENTIS-MUSC-100783, CDR0000387959, MUSC-100783, MUSC-HR-11326|
This phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.
|Intervention model||single group assignment|
Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy
time frame: 57 days
Male participants at least 18 years old.
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis 2. No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery. 3. Performance status 0-2 4. Must meet criteria for acceptable lab values as outlined in the protocol. 5. Peripheral neuropathy must be greater than or equal to 1 6. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. Exclusion Criteria: 1. No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80
|Official title||Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer|
|Principal investigator||David Marshall, MD|
|Description||Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.|
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