Status:
COMPLETED
Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients
Lead Sponsor:
Novartis
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE2
Brief Summary
The present study will provide information on whether the somatostatin analog, octreotide acetate, could have an inhibitory effect on circulating chromogranin A. The demonstration of an antisecretory ...
Eligibility Criteria
Inclusion
- Male patients aged \>18
- ECOG performance status \< 3
- Patients with metastatic prostate cancer currently receiving 1st line hormonal therapy (LHRH agonists or surgical castration) and failing with raising serum PSA
- Biochemical progression documented by three consecutively rising serum PSA measurements, each separated from the other by at least 2 weeks, with the last measurement being 50% or greater than the nadir PSA achieved after the last therapeutic maneuver (i.e. first line hormonal therapy noted above)
- Demonstrated tolerance to a test dose of s.c. octreotide acetate injection at Visit 1
- Elevated (\> 40 U/L according to DAKO Elisa kit) chromogranin A plasma levels documented by at least two consecutive measurements
- Liver function tests \< 2.5 ULN, serum creatinine within normality
- Serum PSA (50% increased value) above 4 ng/mL for patients with intact prostate and \> 0.8 ng/mL for post prostatectomy patients at study entry
- Immediate history of rising PSA \< 10 months
- Castrate levels of testosterone (\< 30 ng/dL)
- Life expectancy of \> 6 months
- Signed informed consent prior to initiation of any procedure
Exclusion
- Prior chemotherapy or other systemic anticancer therapy except for LHRH agonists, and/or non-steroidal anti-androgens (eg, flutamide, bicalutamide or nilandron)
- Palliative radiotherapy less than 6 weeks (42 days) prior to planned entry date
- Other investigational drugs within the past 28 days
- Long-term (\> 3 months) treatment with proton pump inhibitors
- Uncontrolled blood hypertension
- Other malignancies within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer
- Patients with another non-malignant disease which would confound the evaluation of the primary endpoints or prevent the patient from complying with the protocol
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00166725
Start Date
February 1 2004
Last Update
November 19 2009
Active Locations (1)
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1
Orbassano
Orbassano, Italy