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Trial record 50 of 430 for:    ifosfamide

Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis

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ClinicalTrials.gov Identifier: NCT00512096
Recruitment Status : Completed
First Posted : August 7, 2007
Results First Posted : December 8, 2010
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Penile Cancer
Interventions Drug: Ifosfamide
Drug: Paclitaxel (Taxol)
Drug: Cisplatin
Enrollment 30
Recruitment Details Recruitment period 17-AUG-99 to 15-OCT-08; all participants were recruited at MD Anderson Cancer Center
Pre-assignment Details  
Arm/Group Title Cisplatin + Ifosfamide + Paclitaxel
Hide Arm/Group Description 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
Period Title: Overall Study
Started 30
Completed 23
Not Completed 7
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             2
Lack of Efficacy             3
Arm/Group Title Cisplatin + Ifosfamide + Paclitaxel
Hide Arm/Group Description 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 Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
57.5
(24 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
0
   0.0%
Male
30
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Pathologic Complete Remission (pCR)
Hide Description Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.
Time Frame restaging with second and fourth 21-day cycles followed by surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed chemotherapy without progression then had surgical resection.
Arm/Group Title Cisplatin + Ifosfamide + Paclitaxel
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
3
Time Frame Nine years and 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cisplatin + Ifosfamide + Paclitaxel
Hide Arm/Group Description 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
All-Cause Mortality
Cisplatin + Ifosfamide + Paclitaxel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cisplatin + Ifosfamide + Paclitaxel
Affected / at Risk (%) # Events
Total   3/30 (10.00%)    
Cardiac disorders   
myocarcial ischemia  1  2/23 (8.70%)  2
Immune system disorders   
allergic reaction  1  1/23 (4.35%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Cisplatin + Ifosfamide + Paclitaxel
Affected / at Risk (%) # Events
Total   13/30 (43.33%)    
Blood and lymphatic system disorders   
anemia  1 [1]  1/30 (3.33%)  1
Neutropenia  1 [2]  1/30 (3.33%)  1
febrile neutropenia  1 [3]  1/30 (3.33%)  1
thrombocytopenia  1 [4]  1/30 (3.33%)  1
Infections and infestations   
infection  1 [5]  5/30 (16.67%)  5
Metabolism and nutrition disorders   
hyperglycemia  1 [6]  1/30 (3.33%)  1
Nervous system disorders   
neuropathy motor  1 [6]  1/30 (3.33%)  1
Vascular disorders   
deep vein thrombosis  1 [7]  1/30 (3.33%)  1
central venous catheter related thrombosis  1 [3]  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
[1]
grade 3 only, no grade 4 events
[2]
grade 4 only, no grade 3 events
[3]
grade 3, no grade 4 events
[4]
grade 3 event, no grade 4
[5]
grade 3 events, no grade 4
[6]
grade 3 event, no grade 4 events
[7]
no grade 4 events
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Cherie A. Perez
Organization: UT MD Anderson Cancer Center
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00512096     History of Changes
Other Study ID Numbers: ID99-194
First Submitted: August 6, 2007
First Posted: August 7, 2007
Results First Submitted: November 3, 2010
Results First Posted: December 8, 2010
Last Update Posted: August 1, 2012