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

Completed

• Conditions: 10004994; Bladder carcinoma; bladder cancer

• Registration Number: NL-OMON34833
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 31

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.
Karnofsky performance of * 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.

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acute Toxicity rate during radiotherapy with Panitumumab treatment (defined in<br /><br>protocol section 4.4)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br>Complete response rate at 3 months<br /><br>Local control rate at 6, 12, and 18 months, and at 2 years<br /><br>Bladder preservation rate<br /><br>Any grade 3 or 4 adverse event during and within one month after completion<br /><br>of therapy<br /><br><br /><br>Exploratory endpoints<br /><br>% EGFR expression<br /><br>RAS mutational status<br /><br>Response rate in correlation with EGFR and RAS status<br /><br>Response rate in relation to treatment path</p><br>