A study on the efficacy and safety of chemotherapy with paclitaxel, ifosfamide, cisplatin for metastatic penile cancer
Phase 2
- Conditions
- metastatic penile cancer
- Registration Number
- JPRN-UMIN000019798
- Lead Sponsor
- Tohoku university hospital, Department of Urology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with pulmonary fibrosis or interstitial pneumonia, who diagnosed by chest X-ray and clinical symptoms. 2.Patients with NYHA Class III or IV heart failure and/or patients who have a history of myocardial infarction within 6 months. 3. Patients with severe infection. 4.Patients with severe comorbidity (include uncontrolled diabetes mellitus in spite of insulin therapy). 5. Patients with severe drug allergy. 6.Patients with multiple active primary cancers. 7.Patients who wish to partner pregnancy in course of chemotherapy or within 6 months from the final chemotherapy. 8.Patients who are not suitable for chemotherapy with any reason are excluded by physician's judgment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate (complete remission + partial response). Contrast enhanced computed tomography imaging is performed after the second cycle of chemotherapy and at the completion of chemotherapy. Tumor responses are assessed by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Secondary Outcome Measures
Name Time Method 1.Adverse events are assessed according the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 2.Survival analysis Median survival time, progression-free time, progression-free survival, cancer specific survival, overall survival