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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 7, 2003 | ||||||||
| Last Updated Date | April 4, 2009 | ||||||||
| Start Date ICMJE | October 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Response rate as measured by RECIST criteria every 8 weeks during treatment [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Response rate as measured by RECIST criteria every 8 weeks during treatment | ||||||||
| Change History | Complete list of historical versions of study NCT00058448 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Safety as measured by CTC every 4 weeks [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Safety as measured by CTC every 4 weeks | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer | ||||||||
| Official Title ICMJE | Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis | ||||||||
| Brief Summary | 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 metastatic penile cancer. |
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| Detailed Description | OBJECTIVES:
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 20-40 patients will be accrued for this study within 3-5.8 years. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Open Label | ||||||||
| Condition ICMJE | Penile Cancer | ||||||||
| Intervention ICMJE | Drug: docetaxel | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Male | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00058448 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000297621, SWOG-S0224, ECOG-S0224 | ||||||||
| Study Sponsor ICMJE | Southwest Oncology Group | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | December 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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