Condition category
Cancer
Date applied
17/08/2011
Date assigned
17/08/2011
Last edited
09/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Carey Hendron

ORCID ID

Contact details

Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 121 414 3344
c.hendron@bham.ac.uk

Additional identifiers

EudraCT number

2009-014805-15

ClinicalTrials.gov number

Protocol/serial number

7949

Study information

Scientific title

Phase I/II feasibility study of cetuximab with 5-fluorouracil (5FU) and mitomycin C or cisplatin with concurrent radiotherapy in muscle invasive bladder cancer

Acronym

TUXEDO

Study hypothesis

This is a Phase I combination study, followed by an early phase II, single-arm, multicentre, open-label study.

The primary objective of the phase I study is to determine the feasibility and toxicity profile of cetuximab with 5FU and mitomycin C, and in addition to determine the optimal dose of cisplatin in combination with cetuximab. Feasibility will be based on assessment of using the proposed drugs in combination with radical radiotherapy.

The primary objective of the phase II study is to assess preliminary evidence of the efficacy of the treatment selected from phase I, by determining whether a combination of radiotherapy with cetuximab, and chemotherapy, improves cystoscopic local control of advanced bladder cancer at three months after treatment.

Ethics approval

11/LO/1313

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Bladder Cancer; Disease: Bladder (advanced)

Intervention

1. FU: In cohort I, patients receive 5FU in weeks 1 and 4 as a continuous infusion for 5 days (total of 10 days) concurrently with radiotherapy 2. Cetuximab, Loading dose given in week before start of RT, then given on day 1 of each week of RT (weeks 1 - 7)
3. Cisplatin: Patients in cohorts II and III of phase I receive cisplatin on the first day of each week of radiotherapy (weeks 1 - 7)
4. Mitomycin C: In cohort I, patients receive mitomycin C on day 1 only of week 1 of radiotherapy
5. Radical Radiotherapy: All patients in the study receive 64Gy in 32 fractions (given over 5 days in weeks 1 - 7)
Follow Up Length: 18 month(s); Study Entry : Registration only

Intervention type

Drug

Phase

Phase I/II

Drug names

Mitomycin C, 5FU, cetuximab, cisplatin

Primary outcome measures

Feasibility and toxicity; Timepoint(s): Phase I outcome

Secondary outcome measures

Cystoscopic local control at three months post-treatment; Timepoint(s): Primary outcome in Phase II

Overall trial start date

07/11/2011

Overall trial end date

29/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Histologically proven invasive bladder carcinoma [adenocarcinoma, transitional cell carcinoma (TCC) or squamous cell carcinoma (SCC)]
3. Localised muscle invasive carcinoma either surgically or by imaging (T2-T4a N0 M0)
4. World Health Organisation (WHO) performance status grade 0 to 1
5. Adequate haematological function (haemoglobin > 10g/dl; white blood cells (WBC) > 3.0x109/L; absolute neutrophils count (ANC) > 1.5x109/L; platelet count > 100,000/mm3)
6. Adequate hepatic function {billirubin < 1.5 upper limit fo normal (ULN), Alkaline phosphatase (ALP) < 2xULN, [aspartate aminotransferase (AST)/alanine aminotransferase (ALT)] < 3.0xULN}
7. Glomerular filtration rate (GFR) > 40 ml/min [by ethylenediamine tetraacetic acid (EDTA) clearance, 24h urine collection, or Cockcroft-Gault]
8. Available for long-term follow-up
9. Able to receive a radical course of radiotherapy
10. Patient’s written informed consent
11. Have received 3-4 cycles of neo-adjuvant chemotherapy (preferably Gemcitabine/Cisplatin) with a positive response (confirmed by cystoscopy & radiological response) with pre neo-adjuvant imaging computerised tomography (CT) scan or magnetic resonance imaging (MRI) of abdomen and pelvis.; Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Uncontrolled systemic disease which would preclude the patient from participating in the study including severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association (NYHA) III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias
2. Pregnant or breast feeding
3. Concomitant or previous malignancy which is likely to interfere with protocol treatment
4. Inflammatory bowel disease
5. Previous pelvic radiotherapy
6. Bilateral hip replacements compromising accurate radiotherapy planning
7. Evidence of significant clinical disorder, or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
8. Male and female patients (of childbearing age) not using adequate contraception
9. Significant decrease in GFR during previous chemotherapy treatments
10. Widespread carcinoma in situ (CIS), or CIS remote from the muscle invasive tumour
11. Simultaneous upper tract, urethral or prostatic transitional cell carcinoma
12. Untreated hydronephrosis
13. Participation in another trial within the previous 30 days [except for observational studies, e.g. Bladder Cancer Prognosis Programme (BCPP)]

Recruitment start date

07/11/2011

Recruitment end date

29/11/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.birmingham.ac.uk

Funders

Funder type

Government

Funder name

Clinical Trials Awards and Advisory Committee (CTAAC) (UK) Grant Codes: C547/A10900

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

09/03/2016: No publications found, verifying study status with principal investigator.