Trial Outcomes & Findings for Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors (NCT NCT00002558)
NCT ID: NCT00002558
Last Updated: 2016-05-23
Results Overview
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}
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
108 participants
Primary outcome timeframe
2 years
Results posted on
2016-05-23
Participant Flow
Participant milestones
| Measure |
Group A
Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin
|
Group B
Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
16
|
|
Overall Study
COMPLETED
|
92
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group A
Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin
|
Group B
Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
Baseline characteristics by cohort
| Measure |
Group A
n=92 Participants
Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin
|
Group B
n=16 Participants
Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOverall 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}
Outcome measures
| Measure |
Group A
n=91 Participants
Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin
|
Group B
n=15 Participants
Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin
|
|---|---|---|
|
Overall Objective Response
Complete Response (CR)
|
50 participants
|
4 participants
|
|
Overall Objective Response
Incomplete Response (IR)
|
36 participants
|
8 participants
|
|
Overall Objective Response
Partial Response (PR)
|
5 participants
|
3 participants
|
Adverse Events
Group A: <= 6 Cycles of Cisplatin
Serious events: 7 serious events
Other events: 92 other events
Deaths: 0 deaths
Group: B > 6 Cycles of Cisplatin
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: <= 6 Cycles of Cisplatin
n=92 participants at risk
Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin
|
Group: B > 6 Cycles of Cisplatin
n=16 participants at risk
Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin
|
|---|---|---|
|
Nervous system disorders
CNS hemorrhage
|
1.1%
1/92 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Febrile neutropenia
|
1.1%
1/92 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Neurology, other
|
1.1%
1/92 • Number of events 1
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
3.3%
3/92 • Number of events 3
|
0.00%
0/16
|
|
General disorders
Syncope
|
1.1%
1/92 • Number of events 1
|
0.00%
0/16
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Group A: <= 6 Cycles of Cisplatin
n=92 participants at risk
Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin
|
Group: B > 6 Cycles of Cisplatin
n=16 participants at risk
Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
8.7%
8/92 • Number of events 8
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
17.4%
16/92 • Number of events 16
|
18.8%
3/16 • Number of events 3
|
|
General disorders
Alopecia
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin
|
25.0%
23/92 • Number of events 23
|
25.0%
4/16 • Number of events 4
|
|
Infections and infestations
Catheter-related infection
|
6.5%
6/92 • Number of events 6
|
18.8%
3/16 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine
|
8.7%
8/92 • Number of events 8
|
18.8%
3/16 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatology, skin other
|
7.6%
7/92 • Number of events 7
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
8.7%
8/92 • Number of events 8
|
18.8%
3/16 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
6/92 • Number of events 6
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Edema
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Erythema multiforme
|
5.4%
5/92 • Number of events 5
|
0.00%
0/16
|
|
General disorders
Fatigue
|
23.9%
22/92 • Number of events 22
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Fever
|
28.3%
26/92 • Number of events 26
|
25.0%
4/16 • Number of events 4
|
|
Ear and labyrinth disorders
Hearing, other
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin (Hgb)
|
100.0%
92/92 • Number of events 92
|
93.8%
15/16 • Number of events 15
|
|
Blood and lymphatic system disorders
Hemorrhage, other
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
87.0%
80/92 • Number of events 80
|
75.0%
12/16 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.0%
12/92 • Number of events 12
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypermagnesmia
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/92
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.0%
12/92 • Number of events 12
|
18.8%
3/16 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
55.4%
51/92 • Number of events 51
|
68.8%
11/16 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.7%
19/92 • Number of events 19
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
47.8%
44/92 • Number of events 44
|
50.0%
8/16 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
70.7%
65/92 • Number of events 65
|
62.5%
10/16 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.6%
30/92 • Number of events 30
|
25.0%
4/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
68.5%
63/92 • Number of events 63
|
81.2%
13/16 • Number of events 13
|
|
Cardiac disorders
Hypotension
|
6.5%
6/92 • Number of events 6
|
12.5%
2/16 • Number of events 2
|
|
Infections and infestations
Infection with grade 3/4 neutopenia
|
5.4%
5/92 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes
|
97.8%
90/92 • Number of events 90
|
93.8%
15/16 • Number of events 15
|
|
Blood and lymphatic system disorders
Lymphopenia
|
98.9%
91/92 • Number of events 91
|
93.8%
15/16 • Number of events 15
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/92
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophils
|
96.7%
89/92 • Number of events 89
|
93.8%
15/16 • Number of events 15
|
|
General disorders
Pain, other
|
7.6%
7/92 • Number of events 7
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Platelets
|
96.7%
89/92 • Number of events 89
|
93.8%
15/16 • Number of events 15
|
|
Blood and lymphatic system disorders
Prothrombin time (PT)
|
17.4%
16/92 • Number of events 16
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
10.9%
10/92 • Number of events 10
|
18.8%
3/16 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash, desquamation
|
0.00%
0/92
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
SGOT (AST)
|
18.5%
17/92 • Number of events 17
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
SGPT (ALT)
|
26.1%
24/92 • Number of events 24
|
12.5%
2/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis
|
7.6%
7/92 • Number of events 7
|
0.00%
0/16
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
10/92 • Number of events 10
|
12.5%
2/16 • Number of events 2
|
Additional Information
Dr. Robert Motzer
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4312
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place