MDACC Study Summary ID99-194 (Archived)

Study Summary
No. ID99-194:.......Genitourinary......Lance Pagliaro......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	ID99-194

Study Title:	A Phase II Study of (Neoadjuvant Chemotherapy Trial Prior to Extirpative Surgery) for Clinical Stage TanyN2-3M0 Squamous Cell Carcinoma of the Penis

Physician

New Patient Referral



Name:	Lance Pagliaro	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Genitourinary	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients will be seen every week on chemotherapy and every 3 months x 2 years and every 6 months thereafter, after completion of their combined modality therapy.

Treatment Agents:	Cisplatin Ifosfamide Paclitaxel	Home Care:	Patients may receive chemotherapy, administration, weekly CBC, weekly Creatinine, and weekly electrolytes at home.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	This is an inpatient 3-4 day chemotherapy treatment q 21 days x 4, then inpatient hospitalization is required for the surgery.


Description/ Intervention:	The goal of this clinical research study is to see if giving chemotherapy before surgery can make the surgery more effective. Another goal is to see if this can stop the cancer from spreading to other parts of the body. The safety of this treatment will also be studied.

Study Objectives / Outcomes

1. To evaluate the feasibility and efficacy of multimodality treatment (neoadjuvant chemotherapy prior to extirpative surgery) for clinical stage T_XN_2-3M₀ squamous cell carcinoma of the penis.

Study Status Information



Study Activation / Registration Date:	08/17/1999

IRB Review and Approval Date:	11/04/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00512096
Study Information on Clinical Trials Registry (clinicaltrials.gov)