Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 57 for:    "Germ Cells Tumors" | "Carboplatin"

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors

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.
 
ClinicalTrials.gov Identifier: NCT00002558
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Extragonadal Germ Cell Tumor
Ovarian Cancer
Testicular Germ Cell Tumor
Interventions Biological: filgrastim
Drug: carboplatin
Drug: etoposide
Drug: ifosfamide
Drug: paclitaxel
Procedure: peripheral blood stem cell transplantation
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B
Hide Arm/Group Description Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
Period Title: Overall Study
Started 92 16
Completed 92 15
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Group A Group B Total
Hide Arm/Group Description Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin Total of all reporting groups
Overall Number of Baseline Participants 92 16 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 16 participants 108 participants
<=18 years
3
   3.3%
0
   0.0%
3
   2.8%
Between 18 and 65 years
89
  96.7%
16
 100.0%
105
  97.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 16 participants 108 participants
Female
2
   2.2%
1
   6.3%
3
   2.8%
Male
90
  97.8%
15
  93.8%
105
  97.2%
1.Primary Outcome
Title Overall Objective Response
Hide Description Overall Objective Response will be assessed prior to dose-intensive therapy and at the completion of therapy. Complete disappearance of all clinical, radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). Patients must be free of disease for a minimum of 4 weeks. Partial Response: Complete disappearance of all biochemical evidence of disease in patients without a surgical procedure for a residual radiographic mass. Patients must demonstrate no biochemical recurrence or progression of radiographic masses for a minimum of four weeks (PR to chemotherapy}
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:
Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
Overall Number of Participants Analyzed 91 15
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 50 4
Incomplete Response (IR) 36 8
Partial Response (PR) 5 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A: <= 6 Cycles of Cisplatin Group: B > 6 Cycles of Cisplatin
Hide Arm/Group Description Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
All-Cause Mortality
Group A: <= 6 Cycles of Cisplatin Group: B > 6 Cycles of Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group A: <= 6 Cycles of Cisplatin Group: B > 6 Cycles of Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/92 (7.61%)      2/16 (12.50%)    
Cardiac disorders     
Hypotension  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders     
Diarrhea  1  0/92 (0.00%)  0 1/16 (6.25%)  1
General disorders     
Febrile neutropenia  1  1/92 (1.09%)  1 0/16 (0.00%)  0
Syncope  1  1/92 (1.09%)  1 0/16 (0.00%)  0
Infections and infestations     
Catheter related infection  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Infection  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Nervous system disorders     
CNS hemorrhage  1  1/92 (1.09%)  1 0/16 (0.00%)  0
Neurology, other  1  1/92 (1.09%)  1 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary, other  1  3/92 (3.26%)  3 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-2.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A: <= 6 Cycles of Cisplatin Group: B > 6 Cycles of Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/92 (100.00%)      15/16 (93.75%)    
Blood and lymphatic system disorders     
Hemoglobin (Hgb)  1  92/92 (100.00%)  92 15/16 (93.75%)  15
Hemorrhage, other  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Leukocytes  1  90/92 (97.83%)  90 15/16 (93.75%)  15
Lymphopenia  1  91/92 (98.91%)  91 15/16 (93.75%)  15
Neutrophils  1  89/92 (96.74%)  89 15/16 (93.75%)  15
Platelets  1  89/92 (96.74%)  89 15/16 (93.75%)  15
Prothrombin time (PT)  1  16/92 (17.39%)  16 1/16 (6.25%)  1
Partial thromboplastin time (PTT)  1  10/92 (10.87%)  10 3/16 (18.75%)  3
SGOT (AST)  1  17/92 (18.48%)  17 0/16 (0.00%)  0
SGPT (ALT)  1  24/92 (26.09%)  24 2/16 (12.50%)  2
Cardiac disorders     
Erythema multiforme  1  5/92 (5.43%)  5 0/16 (0.00%)  0
Hypotension  1  6/92 (6.52%)  6 2/16 (12.50%)  2
Ear and labyrinth disorders     
Hearing, other  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders     
Abdominal pain/cramping  1  8/92 (8.70%)  8 0/16 (0.00%)  0
Constipation  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Diarrhea  1  8/92 (8.70%)  8 3/16 (18.75%)  3
Vomiting  1  10/92 (10.87%)  10 2/16 (12.50%)  2
General disorders     
Alopecia  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Edema  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Fatigue  1  22/92 (23.91%)  22 2/16 (12.50%)  2
Fever  1  26/92 (28.26%)  26 4/16 (25.00%)  4
Pain, other  1  7/92 (7.61%)  7 0/16 (0.00%)  0
Infections and infestations     
Catheter-related infection  1  6/92 (6.52%)  6 3/16 (18.75%)  3
Infection with grade 3/4 neutopenia  1  5/92 (5.43%)  5 1/16 (6.25%)  1
Metabolism and nutrition disorders     
Alkaline phosphatase  1  16/92 (17.39%)  16 3/16 (18.75%)  3
Bilirubin  1  23/92 (25.00%)  23 4/16 (25.00%)  4
Creatinine  1  8/92 (8.70%)  8 3/16 (18.75%)  3
Hyperglycemia  1  80/92 (86.96%)  80 12/16 (75.00%)  12
Hyperkalemia  1  12/92 (13.04%)  12 0/16 (0.00%)  0
Hypermagnesmia  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Hypernatremia  1  0/92 (0.00%)  0 2/16 (12.50%)  2
Hypertriglyceridemia  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Hypoalbuminemia  1  12/92 (13.04%)  12 3/16 (18.75%)  3
Hypocalcemia  1  51/92 (55.43%)  51 11/16 (68.75%)  11
Hypoglycemia  1  19/92 (20.65%)  19 2/16 (12.50%)  2
Hypokalemia  1  44/92 (47.83%)  44 8/16 (50.00%)  8
Hypomagnesemia  1  65/92 (70.65%)  65 10/16 (62.50%)  10
Hyponatremia  1  30/92 (32.61%)  30 4/16 (25.00%)  4
Hypophosphatemia  1  63/92 (68.48%)  63 13/16 (81.25%)  13
Nervous system disorders     
Dizziness  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Neuropathy-sensory  1  0/92 (0.00%)  0 2/16 (12.50%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Dyspnea  1  6/92 (6.52%)  6 2/16 (12.50%)  2
Thrombosis  1  7/92 (7.61%)  7 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatology, skin other  1  7/92 (7.61%)  7 1/16 (6.25%)  1
Rash, desquamation  1  0/92 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-2.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Motzer
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-422-4312
EMail: motzerr@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00002558     History of Changes
Other Study ID Numbers: 93-162
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-93162
NCI-V94-0407
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: December 21, 2015
Results First Posted: May 23, 2016
Last Update Posted: May 23, 2016