Phase II trial evaluating combined image guided radiotherapy with Panitumumab (Vectibix®) in patients with muscle invasive transitional cell carcinoma of the bladder

• Conditions: patients with muscle invasive transitional cell carcinoma of the bladder; MedDRA version: 12.1Level: LLTClassification code 10005017Term: Bladder carcinoma stage 0, with cancer in situ; MedDRA version: 12.1Level: LLTClassification code 10005019Term: Bladder carcinoma stage I, with cancer in situ; MedDRA version: 12.1Level: LLTClassification code 10005021Term: Bladder carcinoma stage II

• Registration Number: EUCTR2009-018246-38-NL
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria

Signed written informed consent.
Histologically confirmed bladder carcinoma stage (including previous treatment):
T2 N0 M0, refusing surgery and not eligible for brachytherapy
T3-4a N0 M0
T1-4a pN1 M0: with no evidence of lymphnode disease as assessed by CT-scan
and pN1 before neoadjuvant chemotherapy as assessed by lymphadenectomy. CR
or PR following neoadjuvant chemotherapy as assessed by CT-scan.
T1-4a N1-2 M0 with evidence of lymphnode disease prior to chemotherapy as
assessed by CT-scan and pN0-1 after neoadjuvant chemotherapy as assessed by
lymphadenectomy.

a Karnofsky performance of more or equl 70 prior to chemotherapy and prior to
combined Panitumumab/radiotherapy treatment.
Hematopoietic function: Neutrophils = 1.5 x 109/L, platelets = 100 x 109/L,
leucocytes> 3,000/mm3 and hemoglobin = 9 g/dL.
Hepatic function: Total bilirubin = 1.5 times the upper normal limit (UNL), ASAT = 2.5
x UNL and ALAT = 2.5 x UNL.
Renal function: Creatinin clearance = 50 mL/min (calculated clearance).
Metabolic function: Magnesium = lower limit of normal and Calcium = lower limit of
normal.
Adequate follow-up possibilities for at least two years.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Evidence of M+ (all patients will undergo a pelvic lymphadenectomy prior to
chemoradiation).
Prior chemotherapy or radiotherapy to the pelvis.
Prior treatment with anti EGFr and/or anti VEGF treatment.
Previous malignancy except skin carcinoma (basal cell and squamous cell carcinoma).
Candidate for brachytherapy.
No adequate bladder function (functional capacity < 100 cc, frequency > 1/h).
Clinically significant cardiovascular disease (including myocardial infarction, unstable
angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) ? 1 year before enrollment/randomization.
History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence
of interstitial lung disease on baseline chest CT scan.
Subject pregnant or breast feeding, or planning to become pregnant within 6
months after the end of treatment.
Subject (male or female) is not willing to use highly effective methods of
contraception (per institutional standard) during treatment and for 6 months (male
or female) after the end of treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified