Trial Outcomes & Findings for Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma (NCT NCT02272816)
NCT ID: NCT02272816
Last Updated: 2019-01-25
Results Overview
Number of participants progression free 2 years after registration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
2 years
Results posted on
2019-01-25
Participant Flow
Participant milestones
| Measure |
Carboplatin AUC-10
Carboplatin area under the curve (AUC)-10: Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Carboplatin AUC-10
Carboplatin area under the curve (AUC)-10: Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Carboplatin AUC-10
n=48 Participants
Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=48 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=48 Participants
|
|
Region of Enrollment
United Kingdom
|
48 Participants
n=48 Participants
|
|
Primary Tumour
Testis
|
46 Participants
n=48 Participants
|
|
Primary Tumour
Mediastinum
|
1 Participants
n=48 Participants
|
|
Primary Tumour
Retroperitoneum
|
1 Participants
n=48 Participants
|
|
Sites of Metastases
Lung
|
2 Participants
n=48 Participants
|
|
Sites of Metastases
Lymph node
|
29 Participants
n=48 Participants
|
|
Sites of Metastases
Other
|
9 Participants
n=48 Participants
|
|
Sites of Metastases
Not recorded
|
8 Participants
n=48 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
ECOG PS = 0
|
41 Participants
n=48 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
ECOG PS = 1
|
2 Participants
n=48 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
ECOG PS = 2
|
0 Participants
n=48 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
ECOG PS = 3
|
0 Participants
n=48 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Not recorded
|
5 Participants
n=48 Participants
|
|
Stage of Disease
2A
|
13 Participants
n=48 Participants
|
|
Stage of Disease
2B
|
23 Participants
n=48 Participants
|
|
Stage of Disease
2C
|
11 Participants
n=48 Participants
|
|
Stage of Disease
N/A
|
1 Participants
n=48 Participants
|
|
Tumour Marker: Alpha-fetoprotein
Normal
|
48 Participants
n=48 Participants
|
|
Tumour Marker: Alpha-fetoprotein
Elevated
|
0 Participants
n=48 Participants
|
|
Tumour Marker: Beta-Human Chorionic Gonadotropin
Normal
|
36 Participants
n=48 Participants
|
|
Tumour Marker: Beta-Human Chorionic Gonadotropin
Elevated
|
12 Participants
n=48 Participants
|
|
Tumour Marker: Lactate Dehydrogenase
Normal
|
34 Participants
n=48 Participants
|
|
Tumour Marker: Lactate Dehydrogenase
Elevated (< 3 x ULN)
|
11 Participants
n=48 Participants
|
|
Tumour Marker: Lactate Dehydrogenase
Elevated (≥ 3 x ULN)
|
2 Participants
n=48 Participants
|
|
Tumour Marker: Lactate Dehydrogenase
Not recorded
|
1 Participants
n=48 Participants
|
|
Glomerular Filtration Rate
25 - 120 ml/min
|
35 Participants
n=48 Participants
|
|
Glomerular Filtration Rate
> 120 ml/min
|
13 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All participants who received at least one dose of study treatment.
Number of participants progression free 2 years after registration.
Outcome measures
| Measure |
Carboplatin AUC-10
n=48 Participants
Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
|
|---|---|
|
2 - Year Progression Free Survival
|
46 Participants
|
SECONDARY outcome
Timeframe: 21 daysPopulation: All participants who completed one cycle of treatment and underwent PET-CT scan on day 17-21.
Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment.
Outcome measures
| Measure |
Carboplatin AUC-10
n=47 Participants
Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
|
|---|---|
|
Metabolic Response Rate
CR
|
21 Participants
|
|
Metabolic Response Rate
PR
|
26 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants who received at least one dose of study treatment.
Survival status at 2 years after registration.
Outcome measures
| Measure |
Carboplatin AUC-10
n=48 Participants
Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
|
|---|---|
|
Overall Survival
Alive
|
48 Participants
|
|
Overall Survival
Deceased
|
0 Participants
|
Adverse Events
Carboplatin AUC-10
Serious events: 12 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboplatin AUC-10
n=48 participants at risk
Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
|
|---|---|
|
Vascular disorders
Deep vein thrombosis
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Vascular disorders
Hypotension
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Vascular disorders
Peripheral ischaemia
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
4/48 • Number of events 5 • Start of treatment until 30 days after last dose.
|
|
Nervous system disorders
Headache
|
4.2%
2/48 • Number of events 2 • Start of treatment until 30 days after last dose.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
3/48 • Number of events 4 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
2/48 • Number of events 3 • Start of treatment until 30 days after last dose.
|
|
Renal and urinary disorders
Calculus bladder
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
Other adverse events
| Measure |
Carboplatin AUC-10
n=48 participants at risk
Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
|
|---|---|
|
Vascular disorders
Hypertension
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
General disorders
Fatigue
|
91.7%
44/48 • Number of events 111 • Start of treatment until 30 days after last dose.
|
|
General disorders
Pain
|
12.5%
6/48 • Number of events 7 • Start of treatment until 30 days after last dose.
|
|
Psychiatric disorders
Depression
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Psychiatric disorders
Insomnia
|
6.2%
3/48 • Number of events 4 • Start of treatment until 30 days after last dose.
|
|
Psychiatric disorders
Mood swings
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Injury, poisoning and procedural complications
Sunburn
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Investigations
Neutrophil count decreased
|
70.8%
34/48 • Number of events 81 • Start of treatment until 30 days after last dose.
|
|
Investigations
Platelet count decreased
|
58.3%
28/48 • Number of events 53 • Start of treatment until 30 days after last dose.
|
|
Investigations
Weight decreased
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Investigations
Weight increased
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
56.2%
27/48 • Number of events 49 • Start of treatment until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
2/48 • Number of events 2 • Start of treatment until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
4/48 • Number of events 4 • Start of treatment until 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Nervous system disorders
Headache
|
4.2%
2/48 • Number of events 2 • Start of treatment until 30 days after last dose.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.5%
6/48 • Number of events 7 • Start of treatment until 30 days after last dose.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Ear and labyrinth disorders
Tinnitus
|
27.1%
13/48 • Number of events 15 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Constipation
|
35.4%
17/48 • Number of events 26 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.6%
7/48 • Number of events 11 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
2/48 • Number of events 2 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Nausea
|
77.1%
37/48 • Number of events 70 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
16/48 • Number of events 24 • Start of treatment until 30 days after last dose.
|
|
Gastrointestinal disorders
Vomiting
|
29.2%
14/48 • Number of events 19 • Start of treatment until 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
8/48 • Number of events 9 • Start of treatment until 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
3/48 • Number of events 3 • Start of treatment until 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.8%
22/48 • Number of events 38 • Start of treatment until 30 days after last dose.
|
|
Infections and infestations
Infection
|
8.3%
4/48 • Number of events 5 • Start of treatment until 30 days after last dose.
|
|
Infections and infestations
Neutropenic sepsis
|
2.1%
1/48 • Number of events 1 • Start of treatment until 30 days after last dose.
|
Additional Information
Project Lead
Centre for Experimental Cancer Medicine, Barts Cancer Institute, QMUL
Phone: 02078828277
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No PI may present data from his/her centre separately from the rest of the study results unless approved by the Trial Steering Committee and the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER