GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)

Queen Mary University of London

Status and phase: Completed; Phase 2

Conditions: Testicular Neoplasms

Treatments: Drug: Methotrexate; Drug: Epirubicin; Drug: Etoposide; Drug: Pegfilgrastim; Drug: Cisplatin; Drug: Dactinomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT06309732

TE 2006-09 (Other Identifier)

2006-001963-52 (EudraCT Number)

4491

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

GAMEC - S

Experimental group

Description:

Day 4 PEG Filgrastim 6mg Day 1 Actinomycin D 1mg/m2 Day 1 Methotrexate (dependent on creatinine clearance) Days 1,2, 3, 4 Etoposide 90mg/m2 Days 2, 3 Cisplatin 50mg/m2 Day 8 Cisplatin 50mg/m2 (cycle 1\&2 only)

Treatment:

Drug: Cisplatin

Drug: Dactinomycin

Drug: Etoposide

Drug: Methotrexate

GAMEC-A

Experimental group

Description:

Day 1 Actinomycin-D 1m/m2 Day 2, 3 and 8 Methotrexate 8g/m2 (dependent on creatinine clearance) Day 2, 3 and 8 Cisplatin 50mg/m2 (Day 8 dose omitted from week 6 onwards) Day 1 and 2 Epirubicin 37.5mg/m2 Day 3 Pegfilgrastim 6mg Treatment given on weeks 1, 3, 6, 8 and 10.

Treatment:

Drug: Cisplatin

Drug: Dactinomycin

Drug: Epirubicin

Drug: Pegfilgrastim

Drug: Methotrexate