Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients - Full Text View

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 II

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Octreotide Octreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

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:

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 Criteria:

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

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

Study ID Numbers:	CSMS995A2402
First Received:	September 7, 2005
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00166725
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Novartis:

HRPC

octreotide LAR

CgA

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Octreotide

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Gastrointestinal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00166725