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

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.
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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

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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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  Serious Adverse Events

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  Other Adverse Events

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  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:	November 28, 2017