Trial Outcomes & Findings for Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis (NCT NCT00512096)

NCT ID: NCT00512096

Last Updated: 2012-08-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: restaging with second and fourth 21-day cycles followed by surgery
• Results posted on: 2012-08-01

Participant Flow

Recruitment period 17-AUG-99 to 15-OCT-08; all participants were recruited at MD Anderson Cancer Center

Participant milestones

Measure	Cisplatin + Ifosfamide + Paclitaxel 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
Overall Study STARTED	30
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Cisplatin + Ifosfamide + Paclitaxel 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
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	2
Overall Study Lack of Efficacy	3

Baseline Characteristics

Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis

Baseline characteristics by cohort

Measure	Cisplatin + Ifosfamide + Paclitaxel n=30 Participants 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
Age Continuous	57.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

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

Population: Participants who completed chemotherapy without progression then had surgical resection.

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

Outcome measures

Measure	Cisplatin + Ifosfamide + Paclitaxel n=30 Participants 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
Number of Participants With Pathologic Complete Remission (pCR)	3 participants

Adverse Events

Cisplatin + Ifosfamide + Paclitaxel

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cisplatin + Ifosfamide + Paclitaxel n=30 participants at risk 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
Immune system disorders allergic reaction	4.3% 1/23 • Number of events 1 • Nine years and 6 months
Cardiac disorders myocarcial ischemia	8.7% 2/23 • Number of events 2 • Nine years and 6 months

Other adverse events

Measure	Cisplatin + Ifosfamide + Paclitaxel n=30 participants at risk 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
Blood and lymphatic system disorders anemia	3.3% 1/30 • Number of events 1 • Nine years and 6 months
Blood and lymphatic system disorders Neutropenia	3.3% 1/30 • Number of events 1 • Nine years and 6 months
Infections and infestations infection	16.7% 5/30 • Number of events 5 • Nine years and 6 months
Vascular disorders deep vein thrombosis	3.3% 1/30 • Number of events 1 • Nine years and 6 months
Vascular disorders central venous catheter related thrombosis	3.3% 1/30 • Number of events 1 • Nine years and 6 months
Blood and lymphatic system disorders febrile neutropenia	3.3% 1/30 • Number of events 1 • Nine years and 6 months
Metabolism and nutrition disorders hyperglycemia	3.3% 1/30 • Number of events 1 • Nine years and 6 months
Nervous system disorders neuropathy motor	3.3% 1/30 • Number of events 1 • Nine years and 6 months
Blood and lymphatic system disorders thrombocytopenia	3.3% 1/30 • Number of events 1 • Nine years and 6 months

Additional Information

Cherie A. Perez

UT MD Anderson Cancer Center

Email: caperez@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place