Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis

Completed · Phase 2

Conditions studied: Penile Cancer

In brief

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.

Key facts

Study ID

NCT00512096

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

1999-08-01

Expected to finish

2010-08-01

Last updated by the study team

2012-08-01

Who can join

Age: 14 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent must be obtained from each patient prior to study entry.
• Age >/= 14 years of age. Life expectancy greater than or equal to 6 months. PS </= 2 (ECOG).
• 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).
• 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.
• 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.

You may not qualify if…

• Patients with uncontrolled infection or CNS disease.
• Distant metastasis (TNM stage M1, i.e., lung, bone, other visceral sites, lymph node metastasis above the aortic bifurcation).
• 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).
• Prior systemic chemotherapy for penile carcinoma.
• Prior radiation therapy to inguinal or pelvic lymph nodes.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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