Testicular Neoplasms
Conditions
Keywords
Germ cell tumour
Brief summary
St Bartholomew's hospital completed a study using the regimen GAMEC (PEG-filgrastim, actinomycin-D, methotrexate, etoposide, cisplatin). The results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. These results are very encouraging and compare very favourably to other treatment protocols. In reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH (lactate dehydrogenase). LDH is a blood test which monitors cancer activity. Selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. This will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects.
Detailed description
GAMEC-II (GAMEC -S & GAMEC-A) is an open-labelled, non-randomised clinical trial in patients with relapsed germ cell tumours (GCT) and its objectives are: 1. To establish the response rates to GAMEC-S or GAMEC-A 2. To establish the safety and efficacy of substitution of epirubicin for etoposide (GAMEC-A regimen) 3. To establish the toxicity of GAMEC-A 4. To establish progression free survival (PFS) 5. To establish whether shortening GAMEC-S in patients without adverse prognostic factors reduces toxicity without compromising survival.
Interventions
DRUGPegfilgrastim
6mg at each cycle
DRUGDactinomycin
1mg/m2
DRUGMethotrexate
Doses are titrated against renal function. Dosage: 30 mins loading plus 12 hour infusion
DRUGEtoposide
90mg/m2 injection for infusion
DRUGCisplatin
50mg/m2
DRUGEpirubicin
37.5mg/m2
Sponsors
Queen Mary University of London
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Germ Cell Tumour (GCT), relapsed or progressing on or following platinum-based chemotherapy - as evidenced by rising tumour markers or progressive disease on CT scan * Neutrophil count \>1.0 x109/l * Platelets \>70 x109/l * Haemoglobin \>100g/l (may be transfused) * Creatinine clearance should be \>60ml/min. However, if creatinine clearance \<60 ml/min then an EDTA clearance is MANDATORY. (If EDTA clearance is \<60 ml/min then the patient will be excluded.) * Males age \>16 ≤35 years \[decision made on physical fitness to participate\] * ECOG Performance status 0-3 * Full written consent
Exclusion criteria
* Other malignancy except basal cell carcinoma * Evidence of clinically significant cardiac failure, unstable angina or uncontrolled hypertension * Current participation in any other investigational drug study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate to GAMEC-S or GAMEC-A | 6 weekly | Tumour markers, clinical and radiological assessment of disease and/or examination of resected tissue (if surgery is done) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free survival | Monthly for 1 year, 2 monthly for 2nd year, 3 monthly 3rd year, annually there after | CT-scan chest, abdomen and pelvis (continued pelvic scanning is dependent whether disease present) |
| Overall survival | 5 years | — |
Countries
United Kingdom
Outcome results
None listed