Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis

NCT00512096 | Completed Phase 2 Results

• 1 other identifier: ID99-194
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Penile Cancer

Keywords

Genitourinary; Penile Cancer; Neoadjuvant Chemotherapy; Extirpative Surgery; TanyN2-3M0 Squamous Cell Carcinoma of the Penis; Cisplatin; Platinol-AQ; Platinol; CDDP; Ifosfamide; Ifex; Paclitaxel; Taxol

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pathologic Complete Remission (pCR)

  Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.

  restaging with second and fourth 21-day cycles followed by surgery

Study Arms (1)

Cisplatin + Ifosfamide + Paclitaxel

EXPERIMENTAL

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

Drug: Ifosfamide; Drug: Paclitaxel (Taxol); Drug: Cisplatin

Interventions

Ifosfamide DRUG

1200 mg/m\^2 By Vein Over 2 Hours on Days 1-3

Also known as: Ifex

Cisplatin + Ifosfamide + Paclitaxel

Paclitaxel (Taxol) DRUG

175 mg/m\^2 By Vein Over 3 Hours on Day 1

Also known as: Taxol

Cisplatin + Ifosfamide + Paclitaxel

Cisplatin DRUG

25 mg/m\^2 By Vein Over 2 Hours on Days 1-3

Also known as: Platinol-AQ, Platinol, CDDP

Cisplatin + Ifosfamide + Paclitaxel

Eligibility Criteria

• Age: 14 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Pagliaro 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 RESULT

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Penile Neoplasms

Interventions

Ifosfamide; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Cherie A. Perez
• Organization: UT MD Anderson Cancer Center

caperez@mdanderson.org

Study Officials

• Lance Pagliaro, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 7, 2007
• Study Start: August 1, 1999
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 1, 2012
• Results First Posted: December 8, 2010

Record last verified: 2012-07

Locations

US (1)