Plain English Summary
Trial website
Additional identifiers
EudraCT number
2004-000847-79
ClinicalTrials.gov number
NCT00453232
Protocol/serial number
A090011
Study information
Scientific title
A non-randomised phase II pilot study of Accelerated Bleomycin, Etoposide, Platinum (BEP) chemotherapy for intermediate and high risk metastatic germ cell tumours
Acronym
Accelerated BEP
Study hypothesis
To assess the tolerability and toxicity of an accelerated regimen of chemotherapy in patients with germ cell tumours.
Ethics approval
Eastern Multicentre Research Ethics Committee, 07/04/2004, ref: 04/5/024
Study design
Multicentre non-randomised single-arm registration/interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Metastatic germ cell tumour
Intervention
Day 1: etoposide (165 mg/m^2)/cisplatin (50 mg/m^2) (intravenous [IV] infusions)
Day 2: etoposide (165 mg/m^2)/cisplatin (50 mg/m^2)/bleomycin (30,000 units) (IV infusions)
Day 3: etoposide (165 mg/m^2)
Day 4: granulocyte colony-stimulating factor (G-CSF) injection (6 mg)
Day 6, 7 or 8: bleomycin (30,000 units) (IV infusion)
Day 10, 11 or 12: bleomycin (30,000 units) (IV infusion)
This is a single armed trial. Patients are followed-up according to institutional practice, however, the study requires computed tomography (CT), audiometry and lung function tests to be performed at one and two years post-chemotherapy.
Intervention type
Drug
Phase
Phase II
Drug names
Bleomycin, etoposide, platinum (BEP) chemotherapy
Primary outcome measure
The primary endpoint of feasibility will be judged by the results of all of the data via a risk-benefit analysis.
Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0 criteria during treatment, and then via CR51-EDTA for renal function (pre-treatment versus post-treatment). Audiometry and lung function tests (pulmonary vital capacity and diffusing capacity of the lung for carbon monoxide [DLCO]) are standard assessments performed. There is also a clinical assessment of neurotoxicity (including two-point discrimination, Romberg test, tendon reflexes and vibration test, along with NCI CTC neuropathy-motor toxicity and neuro-sensory toxicity assessments).
The patients are also given a simple questionnaire regarding tingling, burning and weakness they have experienced; its location, frequency and impact.
Secondary outcome measures
1. To establish the response rate to this treatment
2. To establish progression free survival
Overall trial start date
01/08/2004
Overall trial end date
01/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients must fulfill all of the following criteria in a particular category:
1. Non-seminoma germ cell tumour (intermediate risk):
1.1. Testis or retroperitoneal primary
1.2. Abnormal markers as below:
1.2.1. Alpha-fetoprotein (AFP) greater than 1,000 and less than 10,000 ng/ml
1.2.2. Human chorionic gonadotropin (HCG) greater than 5,000 and less than 50,000 iu/l
1.2.3. Lactate dehydrogenase (LDH) greater than 1.5 x to less than 10 x the upper limit of normal
1.3. No liver, bone, brain or other non-pulmonary visceral metastasis
1.4. Histological confirmation of non-seminomatous germ cell tumours (NSGCT) is not required if AFP or HCG are grossly elevated
2. Non-seminoma germ cell tumour (poor prognosis):
2.1. Mediastinal primary, or
2.2. Non-pulmonary visceral metastases, or
2.3. Poor markers - any of AFP greater than 10,000 ng/ml, HCG greater than 50,000 iu/l, LDH greater than 10 x upper limit of normal
2.4. Histological confirmation of NSGCT is not required if AFP or HCG are grossly elevated
3. Seminoma (intermediate prognosis):
3.1. Histological confirmation of seminoma is required
3.2. Any primary site
3.3. Non-pulmonary visceral metastases must be present
3.4. Normal AFP
3.5. Any HCG
3.6. Any LDH
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
20
Participant exclusion criteria
1. Aged less than 18 years or over 40 years
2. Female patients
3. Previous malignancy except basal cell carcinoma of the skin
4. Previous chemotherapy or radiotherapy
5. Inadequate renal function - patients with creatinine clearance below 60 ml/min are excluded unless this is due to obstructive uropathy which can be relieved by nephrostomy
6. Neutrophils less than 1.0 x 10^9/L, platelets less than 100,000 prior to commencing treatment
7. Patient unable to understand and consent in English unless a full interpreter service is provided including translation of all documents or the provision of a tape recording of the consultation
Recruitment start date
01/08/2004
Recruitment end date
01/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University NHS Foundation Trust (UK)
Sponsor details
Box 277
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Amgen (UK) - providing discounted Neulasta® (pegfilgrastim) 6 mg/0.6 ml syringes
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21847130