Penile Neoplasm Clinical Trial
— JAVA-POfficial title:
A Phase II Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis
| Verified date | November 2022 |
| Source | University Hospitals Bristol and Weston NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
An evaluation of the activity of cabazitaxel chemotherapy in relapsed cancer of the penis. Safety and tolerability will be monitored and survival will be assessed. It is hypothesised that cabazitaxel is useful in increasing progression free survival in relapsed penile cancer.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | November 16, 2016 |
| Est. primary completion date | November 16, 2016 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Histologically-proven squamous cell carcinoma of the penis - Performance status ECOG 0-2 - Written informed consent - Measurable disease as per RECIST 1.1 - Fit to receive cabazitaxel as second line chemotherapy - Previously received TPF or cisplatin-5FU as first line systemic chemotherapy for penile cancer - Adequate organ function as evidenced by the following peripheral blood counts and serum biochemistry at enrollment: - Neutrophils =1.5 x 109/L - Haemoglobin =10 g/dL - Platelets =100 x 109/L - Total bilirubin <1.5 upper limit of normal (ULN) - Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) =1.5 x ULN - Serum creatinine =1.5 x ULN. (If creatinine is 1.0-1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with a creatinine clearance <60 ml/min should be excluded.) Exclusion Criteria: - Pure veruccous carcinoma of the penis - Squamous carcinoma of the urethra - T1 N1 M0 disease - T2 N1 M0 disease - Unfit for this regimen (as assessed by the multidisciplinary team) - Contraindication to chemotherapy - ECOG Performance Status > 2 - Active Grade =2 peripheral neuropathy - Active secondary cancers - Other concurrent serious illness or medical conditions - Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months. - Uncontrolled diabetes mellitus. - History of severe hypersensitivity reaction (=grade 3) to docetaxel - History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs - Active infection requiring systemic antibiotic or anti-fungal medication - Participation in another clinical trial with any investigational drug within 30 days prior to study registration. - Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments. - Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Bristol Haematology and Oncology Centre, Horfield Road | Bristol | |
| United Kingdom | Universitty College Hospitals NHS Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospitals Bristol and Weston NHS Foundation Trust | Sanofi |
United Kingdom,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete response | Complete response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment | 18 weeks | |
| Primary | Partial response | Partial response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment | 18 weeks | |
| Secondary | Progression free survival | Progression free survival defined as the time from registration to the first of one of the following: development of radiological disease progression (RECIST 1.1) or death from any cause | Until patient progresses, which is approximately 6 weeks after randomisation | |
| Secondary | Overall survival | Overall survival defined as time from registration to the date of death due to from any cause | Until patient dies, which is approximately 3 months after randomisation | |
| Secondary | Acute toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade). | Acute toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse reactions and by grades experienced by the patient collected at study visits and recorded on an Adverse Event Case report form. . | After each cycle (every 3 weeks) for maximally 6 cycles therefore 18 weeks whilst on treatment and at the 3 month visit timepoint | |
| Secondary | Late toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade). | Late toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse reactions and by grades experienced by the patient collected at study visits and recorded on an Adverse Event Case report form. . | From 3 months post treatment Cycle 1 Day 1 to up to 6 months recorded at the 3 month and 6 month timepoint. |