Condition category
Cancer
Date applied
21/04/2008
Date assigned
16/05/2008
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Michael Williams

ORCID ID

Contact details

Oncology Centre (Box 193)
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

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

Ethics approval received from the Eastern Multicentre Research Ethics Committee on the 7th April 2004 (ref: 04/5/024).

Study design

Multicentre, non-randomised, single armed 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 below 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 measures

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

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

Oncology Centre (Box 193)
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

http://www.addenbrookes.org.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded trial (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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes