A Phase II, Open-Label study of Velcade(Bortezomib)for patients with Androgen-Independent Prostate Carcinoma who progressed on or after prior chemotherapy - Velcade Phase II in AIPCa
- Conditions
- Treatment of patients with Androgen-Independent Prostate Carcinoma who progressed on or after prior chemotherapy.
- Registration Number
- EUCTR2006-001933-16-GR
- Lead Sponsor
- Christos N. Papandreou
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
1Signed informed consent.
2Histologic demonstration of adenocarcinoma of the prostate. If no sample of the primary tumor was obtained, biopsy of a metastatic site is sufficient if the tissue stains positive for PSA.
3Androgen-Independent progression of prostate carcinoma, as shown by: Serum testosterone level of < 50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of serum testosterone (LHRH agonists) should continue, and patients must be off anti-androgens, such as flutamide (Eulexin), bicalutamide (Casodex) or nilutamide (Nilandron). They must have no evidence of response at least 4 weeks (6 weeks for bicalutamide) since anti-androgen withdrawal (or progression at any time since anti-androgen withdrawal), and either symptomatic progression, or, if patient is asymptomatic, then progressive measurable or evaluable disease defined as:
-Progressive measurable disease (changes in the size of lymph nodes or parenchymal masses on physical examination or x-ray, as per the RECIST CRITERIA- Attachment 4), or
-Progressive bone metastasis [presence of new lesion(s) on a bone scan]. Patients with progressive bone disease have to have also progressive PSA to be eligible for enrollment in the study, given the difficulty in assessing response in bone, or
-Progressive PSA, is defined as an increase in PSA, as determined by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement.
If the third measurement is not greater than the second measurement, then a fourth measurement must be taken; the fourth measurement must be greater than the second measurement for the patient to be eligible for enrollment in the study.
The confirmatory PSA measurement (i.e., the third or, if applicable, fourth PSA measurement) must be ?5 ng/mL, if the PSA criterion for disease progression is to be used as the only criterion for disease progression, prior to entry into the study [23].
4Patients should have had at least one and up to 2 prior chemotherapy regimens for hormone-refractory prostate cancer, provided that more than 4 weeks (6 weeks for nitrosoureas) have elapsed since the last treatment and patients have recovered from toxicity.
5Up to one prior dose of Strontium-89 (Metastron) or Samarium is allowed, if given more than 12 weeks (4 weeks for Samarium) prior to study entry. Patients may have had radiation therapy (completed more than 4 weeks prior to initiation of the study).
6Previous treatment with PC-SPES, herbal / alternative medicines, anti-angiogenesis inhibitors, immunotherapy, or other non-androgen mediated pathways (such as epidermal growth factor receptor antagonists or farnesyl transferase inhibitors) is allowed, provided that there is unequivocal evidence of disease progression since completion of the therapy and more than 4 weeks (8 weeks for immunotherapy) have elapsed since last treatment.
7Patients must be at least 4 weeks from prior surgery.
8Life expectancy of at least 12 weeks
9Zubrod performance status of < 1 [Attachment 5].
10 A resting Left Ventricular Ejection Fraction (LEVF) > 50%.
11 ALT and AST ?2.5 ? the ULN, or, if the patient has liver metastases, ?5 ? the ULN.
12 Total bilirubin ?1.5 ?the upper limit of normal (ULN).
13 Serum creatinine < 2.0 mg/dl (or, if creatinine > 2 mg/dl, then a creatinine clearance of at least 35 ml/min (measured or estimated by the Cockroft formula: CLcr= [(140-age)
Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
1Patient has never received chemotherapy for prostate carcinoma or has received chemotherapy within four weeks (six weeks for nitrosoureas) or antibody therapy within eight weeks of enrollment.
2Patient has received radiation therapy or Samarium-153 within four weeks of enrollment, or Strontium-89 within 12 weeks of enrollment.
3Patient has not recovered from all serious toxic effects of previous chemotherapy or radiation or antibody therapy.
4Patient received treatment with flutamide within four weeks of enrollment or nilutamide or bicalutamide within six weeks of enrollment and there is no evidence of disease progression since discontinuation of the anti-androgen.
5Patient has had any major surgery within four weeks of enrollment.
6Patient has significant atherosclerotic disease, as defined by:
a) myocardial infarction within six months of enrollment, uncontrolled / unstable angina pectoris or electrocardiographic evidence of acute ischemia
b) clinically significant ventricular arrhythmias,
c) symptomatic congestive heart failure
d) significant conduction abnormalities: 2nd or 3rd degree AV blocks, bifascicular block (defined as Left Anterior Hemiblock in the presence of Right Bundle Branch Block),
e) claudication limiting activity and
f) history of cerebrovascular events within the last year -including transient ischemic attack (TIA)
7Patient has uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension.
8Patient has uncontrolled brain metastases or central nervous system disease.
9Patient has ? Grade 2 peripheral neuropathy or neuropathic pain (per NCI CTCAE v.3.0, Attachment 7).
10 Patient has an uncontrolled inter-current illness (e.g., active infection).
11 Patients with a history of another malignancy (except from superficial bladder cancer or basal cell carcinoma of the skin) within 5 years prior to study entry.
12 Patient has another serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the patient’s ability to provide informed consent or with the completion of treatment according to this protocol.
13 History of allergic reaction attributable to compounds containing boron or mannitol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method