metastatic penile cancer
Conditions
Interventions
The treatment regimen consisted of four cycles of 3 weeks duration each, in which patients received 175 mg/m2 paclitaxel intravenously (IV) over 180 minutes day 1
1.2 g/m2 ifosfamide IV over 120 minutes days 1, 2, and 3
and 25 mg/m2 cisplatin IV over 120 minutes days 1, 2, and 3.
Sponsors
Tohoku university hospital, Department of Urology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients with penile tumor, which has been confirmed to be pathologically squamous cell carcinoma by biopsy of primary lesion. 2. Patients with lymph node metastasis (Tx, N2~3, M0) or distant metastasis in the imaging. 3. Patients with at least one measurable lesion. 4.Patients with ECOG performance status 0-2. 5. Patients who may survive more than three months from the registration date. 6. Patients with major organ function is maintained. WBC: >= 3,000/mm3 PLT: >= 100,000/mm3 AST(GOT) and ALT(GPT): Less than twice the upper limit of the facility reference value Total bilirubin: < 2.0mg/dL conjugated bilirubin: < 1.5mg/dL estimated glomerular filtration rate (eGFR): >=40mL/min 7. Patients who have the consent in writing for the chemotherapy with the off-label use of the anti-cancer agent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShinichi Yamashita
Tohoku university hospital Department of Urology
Outcome results
None listed