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Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin

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ClinicalTrials.gov Identifier: NCT00423852
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : May 18, 2016
Last Update Posted : May 18, 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 Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Ovarian Cancer
Teratoma
Testicular Germ Cell Tumor
Interventions Biological: filgrastim
Drug: carboplatin
Drug: ifosfamide
Drug: paclitaxel
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemotherapy With Stem Cell Support
Hide Arm/Group Description

This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.

filgrastim

carboplatin

ifosfamide

paclitaxel

autologous hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Period Title: Overall Study
Started 26
Completed 23
Not Completed 3
Reason Not Completed
Removed pior to the high-dose portion             3
Arm/Group Title Chemotherapy With Stem Cell Support
Hide Arm/Group Description

This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.

filgrastim

carboplatin

ifosfamide

paclitaxel

autologous hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
1
   3.8%
Between 18 and 65 years
25
  96.2%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
1
   3.8%
Male
25
  96.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title Response
Hide Description

Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary)

Complete Response (CR): A complete response is defined as one of the following:

  • Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy).
  • Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks.
  • Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks.
Time Frame 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy With Stem Cell Support
Hide Arm/Group Description:

This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.

filgrastim

carboplatin

ifosfamide

paclitaxel

autologous hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 12
Incomplete Response (IR) 6
Partial Response (PR) 5
2.Primary Outcome
Title Maximum Tolerated Dose of Ifosfamide
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy With Stem Cell Support
Hide Arm/Group Description:

This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.

filgrastim

carboplatin

ifosfamide

paclitaxel

autologous hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: mg/m2
9990
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy With Stem Cell Support
Hide Arm/Group Description

This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.

filgrastim

carboplatin

ifosfamide

paclitaxel

autologous hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

All-Cause Mortality
Chemotherapy With Stem Cell Support
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy With Stem Cell Support
Affected / at Risk (%) # Events
Total   9/26 (34.62%)    
Blood and lymphatic system disorders   
Thrombosis/thrombus/embolism  1  1/26 (3.85%)  1
Edema: head and neck  1  1/26 (3.85%)  1
Cardiac disorders   
Hypotension  1  1/26 (3.85%)  1
Immune system disorders   
Allerg react/hypersens (incl drug fever)  1  1/26 (3.85%)  1
Infections and infestations   
Infection w/ Gr 3/4 neut, Blood  1  1/26 (3.85%)  1
Inf norm ANC/gr1/2 neut-Catheter-related  1  1/26 (3.85%)  1
Metabolism and nutrition disorders   
Potassium, low (hypokalemia)  1  1/26 (3.85%)  1
Febrile neutropenia  1  1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  1/26 (3.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy With Stem Cell Support
Affected / at Risk (%) # Events
Total   26/26 (100.00%)    
Blood and lymphatic system disorders   
Leukocytes (total WBC)  1  25/26 (96.15%)  100
Lymphopenia  1  26/26 (100.00%)  100
Neutrophils/granulocytes (ANC/AGC)  1  23/26 (88.46%)  100
PTT  1  3/26 (11.54%)  5
Platelets  1  25/26 (96.15%)  100
Cardiac disorders   
Hypotension  1  5/26 (19.23%)  6
Ear and labyrinth disorders   
Tinnitus  1  4/26 (15.38%)  4
Gastrointestinal disorders   
Constipation  1  2/26 (7.69%)  2
Mucositis (Clin exam)- Oral cavity  1  2/26 (7.69%)  2
Mucositis (func/sympt)- Oral cavity  1  2/26 (7.69%)  2
Nausea  1  5/26 (19.23%)  6
Vomiting  1  5/26 (19.23%)  5
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  12/26 (46.15%)  20
Infections and infestations   
Febrile neutropenia  1  7/26 (26.92%)  10
Infection, other  1  2/26 (7.69%)  2
Metabolism and nutrition disorders   
ALT, SGPT  1  19/26 (73.08%)  63
AST, SGOT  1  11/26 (42.31%)  24
Albumin, low (hypoalbuminemia)  1  2/26 (7.69%)  2
Alkaline phosphatase  1  3/26 (11.54%)  3
Amylase  1  2/26 (7.69%)  5
Bilirubin (hyperbilirubinemia)  1  9/26 (34.62%)  14
Creatinine  1  9/26 (34.62%)  35
Glucose, high (hyperglycemia)  1  23/26 (88.46%)  115
Hemoglobin  1  25/26 (96.15%)  100
Magnesium, high (hypermagnesemia)  1  2/26 (7.69%)  2
Magnesium, low (hypomagnesemia)  1  18/26 (69.23%)  45
Phosphate, low (hypophosphatemia)  1  24/26 (92.31%)  100
Potassium, high (hyperkalemia)  1  3/26 (11.54%)  4
Potassium, low (hypokalemia)  1  12/26 (46.15%)  75
Sodium, high (hypernatremia)  1  2/26 (7.69%)  7
Sodium, low (hyponatremia)  1  8/26 (30.77%)  10
Lipase  1  4/26 (15.38%)  18
Nervous system disorders   
Neuropathy: sensory  1  7/26 (26.92%)  12
Renal and urinary disorders   
Renal failure  1  2/26 (7.69%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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. Darren Feldman, Assistant Attending
Organization: Memorial Sloan Kettering Cancer Center
Phone: +1646-422-4491
EMail: Feldmand@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00423852     History of Changes
Other Study ID Numbers: 06-077
MSKCC-06077
First Submitted: January 16, 2007
First Posted: January 18, 2007
Results First Submitted: December 17, 2015
Results First Posted: May 18, 2016
Last Update Posted: May 18, 2016