Clinical trial · Interventional
Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis
A Phase II Study of (Neoadjuvant Chemotherapy Trial Prior to Extirpative Surgery) for Clinical Stage TanyN2-3M0 Squamous Cell Carcinoma of the Penis
NCT00512096CI-TRIAL-00007670completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: -To evaluate the feasibility and efficacy of multimodality treatment (neoadjuvant chemotherapy prior to extirpative surgery) for clinical stage TXN2-3M0 squamous cell carcinoma of the penis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Paclitaxel (Taxol) | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin + Ifosfamide + Paclitaxel
- description
- Cisplatin 25 mg/m\^2 IV Days 1-3; Ifosfamide 1200 mg/m\^2 IV Days 1-3; Paclitaxel 175 mg/m\^2 IV Day 1
- interventionNames
- Drug: Ifosfamide
- Drug: Paclitaxel (Taxol)
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Number of Participants With Pathologic Complete Remission (pCR)
- timeFrame
- restaging with second and fourth 21-day cycles followed by surgery
- description
- Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent must be obtained from each patient prior to study entry. 2. Age \>/= 14 years of age. Life expectancy greater than or equal to 6 months. PS \</= 2 (ECOG). 3. Patients with histologically confirmed squamous cell carcinoma of the penis who present with clinical stage (T(subscript)xN(subscript)2-3M(subscript)0) disease based on the 1987-1992 TNM Staging System and meeting the additional clinicopathologic criteria as defined in the protocol (section 3.1). 4. Patients must have adequate physiologic reserve as evidenced by: absolute neutrophil count (ANC) \>/= 1,500/mm3(superscript) and platelet count \>/= 100,000/mm3. Transaminases \</= 2 times the upper limit of normal. Conjugated bilirubin \</= 1.5mg/dL. Creatinine clearance (either calculated or measured) of \>/= 40ml/minute. 5. No evidence of active ischemia on the EKG and, for patients with significant prior coronary artery disease history, an ejection fraction of more than 40%. No evidence of severe conduction abnormalities on EKG. Exclusion Criteria: 1. Patients with uncontrolled infection or CNS disease. 2. Distant metastasis (TNM stage M1, i.e., lung, bone, other visceral sites, lymph node metastasis above the aortic bifurcation). 3. Patients with clinically negative inguinal examinations or those with palpable adenopathy not meeting pathological or clinical criteria (i.e., minimal nodal metastasis or false positive inguinal examination). 4. Prior systemic chemotherapy for penile carcinoma. 5. Prior radiation therapy to inguinal or pelvic lymph nodes.
References
Publications (1)
- RESULTPagliaro LC, Williams DL, Daliani D, Williams MB, Osai W, Kincaid M, Wen S, Thall PF, Pettaway CA. Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study. J Clin Oncol. 2010 Aug 20;28(24):3851-7. doi: 10.1200/JCO.2010.29.5477. Epub 2010 Jul 12. PMID 20625118