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

Testicular Neoplasms Clinical Trial

— GAMEC-II  

Official title:

GAMEC-SHORT (S) & GAMEC-ANTHRACYCLINE(A) (Combination Chemotherapy With GCSF, Actinomycin-D, Methotrexate, Etoposide and Cisplatin) Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06309732
• Other study ID #: 4491
• Secondary ID: 2006-001963-52TE
• Status: Completed
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: January 2014

Study information

• Verified date: March 2024
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Testicular Neoplasms

Intervention

Drug:
• Pegfilgrastim
6mg at each cycle
• Dactinomycin
1mg/m2
• Methotrexate
Doses are titrated against renal function. Dosage: 30 mins loading plus 12 hour infusion
• Etoposide
90mg/m2 injection for infusion
• Cisplatin
50mg/m2
• Epirubicin
37.5mg/m2

Locations

Country	Name	City	State
United Kingdom	Barts and the London NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate to GAMEC-S or GAMEC-A	Tumour markers, clinical and radiological assessment of disease and/or examination of resected tissue (if surgery is done)	6 weekly
Secondary	Relapse-free survival	CT-scan chest, abdomen and pelvis (continued pelvic scanning is dependent whether disease present)	Monthly for 1 year, 2 monthly for 2nd year, 3 monthly 3rd year, annually there after
Secondary	Overall survival		5 years