Status:
COMPLETED
Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer
Lead Sponsor:
Medical University of South Carolina
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed 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 ener...
Eligibility Criteria
Inclusion
- 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
- No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery.
- Performance status 0-2
- Must meet criteria for acceptable lab values as outlined in the protocol.
- Peripheral neuropathy must be greater than or equal to 1
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Exclusion
- 1\. No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80
Key Trial Info
Start Date :
January 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00099086
Start Date
January 16 2007
End Date
December 13 2023
Last Update
January 31 2024
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