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Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer Clinical research trials and Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer. Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer clinical trial. Human subjects often get the best healthcare available for their Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer  Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer
Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer
For Condition: stage 2 penile cancer,stage 3 penile cancer,stage 4 penile cancer
Status: Not yet recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have locally advanced or metastaticpenile cancer.
Details: OBJECTIVES: - Determine the confirmed complete and partial response rate in patients with locally advanced or metastatic epidermoid carcinoma of the penis treated with docetaxel. - Determine the progression-free and overall survival of patients treated with this drug. - Determine the qualitative and quantitative toxic effects of this drug in these patients. OUTLINE: Patients receive docetaxel IV over 15-30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 3-5.8 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed epidermoid carcinoma of the penis - Distant metastases (M1) OR - Pathologically confirmed regional nodal metastases (N1-3) - Measurable disease - Soft tissue disease irradiated within the past 2 months is not considered measurable disease PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - SGOT no greater than 2.5 times ULN - If SGOT is greater than ULN, alkaline phosphatase must be no greater than 2.5 times ULN - Alkaline phosphatase no greater than 4 times ULN - If alkaline phosphatase is greater than ULN, SGOT must be no greater than 1.5 times ULN Renal - Not specified Other - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission - No grade 2 or greater peripheral neuropathy - No hypersensitivity to drugs formulated with polysorbate 80 (e.g., recombinant interferon alfa-2a, multivitamin infusion, etoposide, infliximab, or recombinant factor VIIa [NovoSeven®]) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for penile cancer Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 28 days since prior radiotherapy and recovered Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TomaszBeer, Study Chair, Oregon Health and Science University
Additional Information:
Study ID Numbers: CDR0000297621; SWOG-S0224
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058448
Other Stage 4 Penile Cancer Studies:
1. Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer
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Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer
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