Trial Outcomes & Findings for Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin (NCT NCT00423852)
NCT ID: NCT00423852
Last Updated: 2016-05-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
2 year
Results posted on
2016-05-18
Participant Flow
Participant milestones
| Measure |
Chemotherapy With Stem Cell Support
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 Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Chemotherapy With Stem Cell Support
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 Study
Removed pior to the high-dose portion
|
3
|
Baseline Characteristics
Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin
Baseline characteristics by cohort
| Measure |
Chemotherapy With Stem Cell Support
n=26 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearResponse 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.
Outcome measures
| Measure |
Chemotherapy With Stem Cell Support
n=23 Participants
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
|
|---|---|
|
Response
Complete Response (CR)
|
12 participants
|
|
Response
Incomplete Response (IR)
|
6 participants
|
|
Response
Partial Response (PR)
|
5 participants
|
PRIMARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Chemotherapy With Stem Cell Support
n=23 Participants
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
|
|---|---|
|
Maximum Tolerated Dose of Ifosfamide
|
9990 mg/m2
|
Adverse Events
Chemotherapy With Stem Cell Support
Serious events: 9 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy With Stem Cell Support
n=26 participants at risk
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
|
|---|---|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
3.8%
1/26 • Number of events 1
|
|
Metabolism and nutrition disorders
Febrile neutropenia
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Blood
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Catheter-related
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.8%
1/26 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombosis/thrombus/embolism
|
3.8%
1/26 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
3.8%
1/26 • Number of events 1
|
|
Immune system disorders
Allerg react/hypersens (incl drug fever)
|
3.8%
1/26 • Number of events 1
|
Other adverse events
| Measure |
Chemotherapy With Stem Cell Support
n=26 participants at risk
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
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT
|
73.1%
19/26 • Number of events 63
|
|
Metabolism and nutrition disorders
AST, SGOT
|
42.3%
11/26 • Number of events 24
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
7.7%
2/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
11.5%
3/26 • Number of events 3
|
|
Metabolism and nutrition disorders
Amylase
|
7.7%
2/26 • Number of events 5
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
34.6%
9/26 • Number of events 14
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatinine
|
34.6%
9/26 • Number of events 35
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
46.2%
12/26 • Number of events 20
|
|
Infections and infestations
Febrile neutropenia
|
26.9%
7/26 • Number of events 10
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
88.5%
23/26 • Number of events 115
|
|
Metabolism and nutrition disorders
Hemoglobin
|
96.2%
25/26 • Number of events 100
|
|
Cardiac disorders
Hypotension
|
19.2%
5/26 • Number of events 6
|
|
Infections and infestations
Infection, other
|
7.7%
2/26 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
96.2%
25/26 • Number of events 100
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
26/26 • Number of events 100
|
|
Metabolism and nutrition disorders
Magnesium, high (hypermagnesemia)
|
7.7%
2/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
69.2%
18/26 • Number of events 45
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis (func/sympt)- Oral cavity
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
19.2%
5/26 • Number of events 6
|
|
Nervous system disorders
Neuropathy: sensory
|
26.9%
7/26 • Number of events 12
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
88.5%
23/26 • Number of events 100
|
|
Blood and lymphatic system disorders
PTT
|
11.5%
3/26 • Number of events 5
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
92.3%
24/26 • Number of events 100
|
|
Blood and lymphatic system disorders
Platelets
|
96.2%
25/26 • Number of events 100
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
11.5%
3/26 • Number of events 4
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
46.2%
12/26 • Number of events 75
|
|
Renal and urinary disorders
Renal failure
|
7.7%
2/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Sodium, high (hypernatremia)
|
7.7%
2/26 • Number of events 7
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
30.8%
8/26 • Number of events 10
|
|
Ear and labyrinth disorders
Tinnitus
|
15.4%
4/26 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
19.2%
5/26 • Number of events 5
|
|
Metabolism and nutrition disorders
Lipase
|
15.4%
4/26 • Number of events 18
|
Additional Information
Dr. Darren Feldman, Assistant Attending
Memorial Sloan Kettering Cancer Center
Phone: +1646-422-4491
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place