Overview

Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Ifosfamide
Isophosphamide mustard
Paclitaxel
Criteria
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 (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 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.