Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

A Randomized, Open Label, Multicenter Study Evaluating the Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166725
• Other study ID #: CSMS995A2402
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: November 18, 2009
• Start date: February 2004

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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 effect of somatostatin analogs could offer a rationale for a large scale randomized study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male patients aged >18

2. ECOG performance status < 3

3. Patients with metastatic prostate cancer currently receiving 1st line hormonal therapy (LHRH agonists or surgical castration) and failing with raising serum PSA

4. 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)

5. Demonstrated tolerance to a test dose of s.c. octreotide acetate injection at Visit 1

6. Elevated (> 40 U/L according to DAKO Elisa kit) chromogranin A plasma levels documented by at least two consecutive measurements

7. Liver function tests < 2.5 ULN, serum creatinine within normality

8. 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

9. Immediate history of rising PSA < 10 months

10. Castrate levels of testosterone (< 30 ng/dL)

11. Life expectancy of > 6 months

12. Signed informed consent prior to initiation of any procedure

Exclusion Criteria:

1. Prior chemotherapy or other systemic anticancer therapy except for LHRH agonists, and/or non-steroidal anti-androgens (eg, flutamide, bicalutamide or nilandron)

2. Palliative radiotherapy less than 6 weeks (42 days) prior to planned entry date

3. Other investigational drugs within the past 28 days

4. Long-term (> 3 months) treatment with proton pump inhibitors

5. Uncontrolled blood hypertension

6. Other malignancies within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer

7. Patients with another non-malignant disease which would confound the evaluation of the primary endpoints or prevent the patient from complying with the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Octreotide LAR

Locations

Country	Name	City	State
Italy	Orbassano	Orbassano

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to 25% decrease in chromogranin A plasma level (evaluation every 4 weeks for the first 12 weeks and every 12 weeks after)
Secondary	PSA response (decrease > 50% or increase > 25% from baseline)
Secondary	Time to symptomatic progression (bone pain increase, deterioration of ECOG performance status)
Secondary	Change in circulating IGF-1, VEGF, IL-6, serum alkaline phosphatase, serum creatinine and serum calcium every 4 weeks for the first 12 weeks and every 12 weeks after