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Trial record 10 of 57 for:    "Germ Cells Tumors" | "Carboplatin"

Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors

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ClinicalTrials.gov Identifier: NCT00467051
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : March 20, 2015
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Childhood Extracranial Germ Cell Tumor
Childhood Extragonadal Malignant Germ Cell Tumor
Childhood Malignant Ovarian Germ Cell Tumor
Childhood Malignant Testicular Germ Cell Tumor
Ovarian Choriocarcinoma
Ovarian Embryonal Carcinoma
Ovarian Yolk Sac Tumor
Recurrent Childhood Malignant Germ Cell Tumor
Recurrent Malignant Testicular Germ Cell Tumor
Recurrent Ovarian Germ Cell Tumor
Testicular Choriocarcinoma
Testicular Embryonal Carcinoma
Testicular Mixed Choriocarcinoma and Embryonal Carcinoma
Testicular Mixed Choriocarcinoma and Yolk Sac Tumor
Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor
Testicular Yolk Sac Tumor
Interventions Drug: Carboplatin
Biological: Filgrastim
Drug: Ifosfamide
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy, Biological Therapy)
Hide Arm/Group Description

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

paclitaxel: Given IV dosage 135 mg/m2/dose

carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2.

ifosfamide: Given IV dosage 1800 mg/m2/dose

filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2

laboratory biomarker analysis: Optional correlative studies

Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Treatment (Chemotherapy, Biological Therapy)
Hide Arm/Group Description

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

paclitaxel: Given IV dosage 135 mg/m2/dose

carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2.

ifosfamide: Given IV dosage 1800 mg/m2/dose

filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2

laboratory biomarker analysis: Optional correlative studies

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
20
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
13.5
(1 to 18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
8
  40.0%
Not Hispanic or Latino
11
  55.0%
Unknown or Not Reported
1
   5.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.0%
White
14
  70.0%
More than one race
0
   0.0%
Unknown or Not Reported
4
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
United States 15
Canada 3
Australia 1
Puerto Rico 1
1.Primary Outcome
Title Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Hide Description Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.
Time Frame At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy, Biological Therapy)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

paclitaxel: Given IV dosage 135 mg/m2/dose

carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2.

ifosfamide: Given IV dosage 1800 mg/m2/dose

filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2

laboratory biomarker analysis: Optional correlative studies

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Responder 12
Non-Responder 8
2.Secondary Outcome
Title The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
Hide Description [Not Specified]
Time Frame Two cycles of chemotherapy; expected to be 42 days of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients.
Arm/Group Title Experimental
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
18
  90.0%
Time Frame [Not Specified]
Adverse Event Reporting Description SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
 
Arm/Group Title Treatment (Chemotherapy, Biological Therapy)
Hide Arm/Group Description

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

paclitaxel: Given IV dosage 135 mg/m2/dose

carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2.

ifosfamide: Given IV dosage 1800 mg/m2/dose

filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2

laboratory biomarker analysis: Optional correlative studies

All-Cause Mortality
Treatment (Chemotherapy, Biological Therapy)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Chemotherapy, Biological Therapy)
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Chemotherapy, Biological Therapy)
Affected / at Risk (%)
Total   18/20 (90.00%) 
Blood and lymphatic system disorders   
Anemia  8/20 (40.00%) 
Blood and lymphatic system disorders - Other  1/20 (5.00%) 
Febrile neutropenia  5/20 (25.00%) 
Cardiac disorders   
Cardiac disorders - Other  1/20 (5.00%) 
Gastrointestinal disorders   
Oral hemorrhage  1/20 (5.00%) 
Vomiting  2/20 (10.00%) 
Infections and infestations   
Bladder infection  1/20 (5.00%) 
Infections and infestations - Other  4/20 (20.00%) 
Investigations   
Alanine aminotransferase increased  2/20 (10.00%) 
Aspartate aminotransferase increased  1/20 (5.00%) 
Lymphocyte count decreased  5/20 (25.00%) 
Neutrophil count decreased  12/20 (60.00%) 
Platelet count decreased  9/20 (45.00%) 
White blood cell decreased  14/20 (70.00%) 
Metabolism and nutrition disorders   
Hyperglycemia  1/20 (5.00%) 
Hypokalemia  3/20 (15.00%) 
Hyponatremia  2/20 (10.00%) 
Hypophosphatemia  1/20 (5.00%) 
Nervous system disorders   
Ataxia  1/20 (5.00%) 
Intracranial hemorrhage  1/20 (5.00%) 
Nervous system disorders - Other  1/20 (5.00%) 
Psychiatric disorders   
Agitation  1/20 (5.00%) 
Confusion  1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Nail loss  1/20 (5.00%) 
Vascular disorders   
Hypotension  1/20 (5.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00467051     History of Changes
Other Study ID Numbers: AGCT0521
NCI-2009-00374 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AGCT0521
CDR0000542424
AGCT0521 ( Other Identifier: Childrens Oncology Group )
AGCT0521 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: April 25, 2007
First Posted: April 27, 2007
Results First Submitted: March 11, 2015
Results First Posted: March 20, 2015
Last Update Posted: August 29, 2018