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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00166725
First received: September 7, 2005
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Octreotide LAR
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time to 25% decrease in chromogranin A plasma level (evaluation every 4 weeks for the first 12 weeks and every 12 weeks after)

Secondary Outcome Measures:
  • PSA response (decrease > 50% or increase > 25% from baseline)
  • Time to symptomatic progression (bone pain increase, deterioration of ECOG performance status)
  • 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

Estimated Enrollment: 40
Study Start Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166725

Locations
Italy
Orbassano
Orbassano, Italy
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00166725     History of Changes
Other Study ID Numbers: CSMS995A2402
Study First Received: September 7, 2005
Last Updated: November 18, 2009
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Novartis:
HRPC
octreotide LAR
CgA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014