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Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470366
First Posted: May 7, 2007
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: May 12, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Ovarian Cancer
Teratoma
Testicular Germ Cell Tumor
Interventions: Biological: pegfilgrastim
Drug: cisplatin
Drug: ifosfamide
Drug: paclitaxel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol Open to Accrual 03/27/2007 Protocol Closed to Accrual 8/13/2013 Primary Completion Date 06-13-2016 Recruitment Location is the medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Paclitaxel, Ifosfamide, and Cisplatin

-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.

pegfilgrastim

cisplatin

ifosfamide

paclitaxel


Participant Flow:   Overall Study
    Paclitaxel, Ifosfamide, and Cisplatin
STARTED   60 
COMPLETED   56 
NOT COMPLETED   4 
Adverse Event                3 
Poor compliance                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paclitaxel, Ifosfamide, and Cisplatin

-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.

pegfilgrastim

cisplatin

ifosfamide

paclitaxel


Baseline Measures
   Paclitaxel, Ifosfamide, and Cisplatin 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Median (Full Range)
 28 
 (18 to 56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1   1.7% 
Male      59  98.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      12  20.0% 
Not Hispanic or Latino      45  75.0% 
Unknown or Not Reported      3   5.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   3.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   3.3% 
White      51  85.0% 
More than one race      0   0.0% 
Unknown or Not Reported      5   8.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   60 


  Outcome Measures
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1.  Primary:   Rate of Complete Response   [ Time Frame: 3 years ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Up to 8 years ]

3.  Secondary:   Participants' Overall Response   [ Time Frame: 3 years ]

4.  Secondary:   Percentage of Participants With Progression Free Survival   [ Time Frame: 3 years ]

5.  Secondary:   Number of Patients With Treatment Related Toxicity   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Darren Feldman, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-422-4491
e-mail: feldmand@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00470366     History of Changes
Other Study ID Numbers: 07-044
MSKCC-07044
First Submitted: May 3, 2007
First Posted: May 7, 2007
Results First Submitted: May 12, 2017
Results First Posted: October 24, 2017
Last Update Posted: October 24, 2017