Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Gastrointestinal Agents

Androgens

Somatostatin

Octreotide

Antineoplastic Agents, Hormonal

Sandostatin 30mg intramuscular every 28 days

Sandostatin

Charles Ryan, MD

This is an open label, single center Phase II trial of Sandostatin LAR in patients with hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg intramuscularly every 28 days. Patients will be treated until the time of disease progression, unacceptable toxicity or withdrawal of consent. The study will require 27 evaluable patients.

Primary Objective:

To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR.

Secondary Objective:

To evaluate the effects of Sandostatin LAR on circulating levels of Insulin Growth Factor-1 and Insulin Growth Factor Binding Protein 1.

To evaluate the safety of Sandostatin LAR in this patient population. To evaluate the pre versus post treatment mitogenic effects of serum derived from subjects with prostate cancer compared to pretreatment serum.

Patients with androgen independent prostate cancer who do not have bone or visceral metastases are selected for this trial because they are a patient population that is likely to have no symptoms from the disease or rapid progression that would suggest the need for chemotherapy. Additionally, given the preclinical data suggesting that IGF-1 expression and signaling occurs concomitantly with the onset of androgen independent growth, it is felt that testing in the "early" androgen independent state is warranted. This trial is consistent with overall goal to develop IGF-1 targeted therapies in patients with disease progression and a lower disease burden.

Sandostatin for Patients With Androgen Independent Prostate Cancer

A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer

Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.

Serum was batched and IGF and IGFBP levels were assayed at one time at the end of the study using an enzyme-linked immunoabsorbent assay (ELISA) method by Diagnostic Systems Laboratories (Webster, TX).

Novartis

University of California, San Francisco

Octreotide acetate 30mg intramuscular every 28 days

Octreotide Acetate

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Prostatectomy

Radiation Therapy

Androgen Deprivation

Type of therapy prior to study enrollment

Primary therapy

PSA was measured by chemiluminescent immunoassay on the Immulite 2000 analyzer (Siemens Healthcare Diagnostics, Deerfield, IL)

Median PSA

A Gleason score is assigned by a pathologist based on the sum of two numbers: the first number is the grade of the most common tumor pattern, the second number is the grade of the second most common pattern. For example, if the most common tumor pattern was grade 3, but some cells were found to be grade 4, the Gleason Score would be 3+4 = 7. The Gleason Score ranges from 2 to 10, with 10 having the worst prognosis.

Gleason Score

Hemoglobin

Charles J. Ryan, MD

n=27 was determined to be sufficient to test for a 20% PSA response proportion compared with a null hypothesis of 5%. A two-stage design was employed to carry out an interim analysis for efficacy. As no patient showed a PSA decline among the first 13 accrued after 3 cycles (the first evaluation of PSA response), accrual was discontinued

PSA Response

IGF-1

IGFBP-1

Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.

Grade 4-5 Adverse Events

The trial was closed for futility after no PSA responses were observed among the first 13 patients, and this analysis was not performed

Pre Versus Post Treatment Mitogenic Effects.

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

David Spiegel

The purpose of this study is to learn about the effects of stress on hormones, the relationship between these hormones and cancer progression.

The purpose of this study is to investigate stress and tonic activation of diurnal cortisol in aging metastatic breast cancer patients; feedback inhibition \& activation of cortisol; and stress-induced phasic activation of cortisol.

Stress, Diurnal Cortisol, and Breast Cancer Survival

National Institute on Aging (NIA)

Stanford University

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Bevacizumab

Pertuzumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers

15 mg/kg IV Day 1. The first dose should be administered over

90 minutes. If no adverse reactions occur after the initial dose, the second dose should

be administered over a minimum of 60 minutes. If no adverse reactions occur after the

second dose, all subsequent doses should be administered over a minimum of 30

minutes. Bevacizumab will be infused prior to pertuzumab.

840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes. Otherwise, pertuzumab should be infused over 60 minutes. Patients should be observed for 30 minutes after completing the pertuzumab infusion.

If a patient misses a dose of pertuzumab for 1 cycle (i.e., 2 sequential cycles or administrations are 6 weeks or more apart), a re-loading dose (840 mg) of pertuzumab should be given. If re-loading pertuzumab is administered, subsequent doses of 420 mg will then be given every 3 weeks, starting 3 weeks later.

30 mg will be given every 28 days by IM injection. The dose of sandostatin may be increased, at the discretion of the treating physician, if necessary to control symptoms related to tumor secretion of vasoactive peptides.

Sandostatin LAR® Depot

Johanna C Bendell, S.B., M.D.

The purpose of this Phase II trial will be to define the activity of a VEGF inhibitor

bevacizumab, HER1/HER2 inhibitor pertuzumab, and sandostatin for patients with

advanced neuroendocrine cancers. In particular, the efficacy of bevacizumab and

pertuzumab treatment is of great interest. The primary endpoint of this trial will be

response rate. Toxicity and progression-free survival will be obtained and evaluated.

* To determine overall response rate of patients with low grade neuroendocrine cancer when treated with the combination of bevacizumab, pertuzumab and sandostatin LAR®.
* To determine the disease control rate (objective response + stable disease), time to treatment progression, progression-free survival, and overall survival in patients with advanced low grade neuroendocrine cancer when treated with bevacizumab, pertuzumab and Sandostatin LAR® treatment.
* To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer.

Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers

Phase II Study of the Combination of Bevacizumab, Pertuzumab, and Sandostatin for Patients With Advanced Neuroendocrine Cancers.

The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer - defined by grade 3/4, treatment-related toxicity

The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

The Percentage of Patients Who Experience an Objective Benefit From Treatment or Experience Stable Disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither Sufficient Shrinkage to Qualify For PR, Nor Sufficient Increase to Qualify for Progressive Disease; Disease Control Rate = CR + PR + SD.

Genentech, Inc.

SCRI Development Innovations, LLC

Includes adverse events of all grades, regardless of their relationship to study treatment

Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over

90 minutes. If no adverse reactions occur after the initial dose, the second dose should

be administered over a minimum of 60 minutes. If no adverse reactions occur after the

second dose, all subsequent doses should be administered over a minimum of 30

minutes. Bevacizumab will be infused prior to pertuzumab.

Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.

Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection.

All Patients

Age, Continuous

John D Hainsworth, MD

Typical Carcinoid

Patients with pancreatic islet cell disease

Pancreatic Islet Cell

All patients on study (treatment is same for all patients)

Objective Response Rate (ORR)

Hypertension

Pain

Left ventricular systolic dysfunction

Diarrhea

Anemia

Leukopenia

Define Toxicity and Safety

Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)

Progression-Free Survival (PFS)

Overall Survival (OS)

Disease Control Rate

Symptoms and General Pathology

Gland and Hormone Related Diseases

Substance Related Disorders

Syndrome

Endocrine Gland Neoplasms

Carcinoid Tumor

Malignant Carcinoid Syndrome

Serotonin Syndrome

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Carcinoid Syndrome

All patients will be treated with octreotide LAR intramuscular injections at maximum doses of 60 mg every 4 weeks or a frequency up to 30 mg octreotide LAR each 2 weeks. Change of dose or frequency is left at the discretion of the investigator until symptom control is obtained.

Ivan Borbath, Prof

This is a multi-centric prospective interventional study in which patients with a symptomatic GEP-NET will receive octreotide LAR every 2, 3 or 4 weeks. The basal dose and the dose adaptation will be left at the discretion of the investigator depending on the rate of symptom control. Dose increase up to doses of 60 mg octreotide every 4 weeks, or increase of frequency up to 30 mg every 2 weeks can be done to obtain control of carcinoid symptoms, defined by at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. If only one symptom is present, analysis will be done for that symptom only: refer to table in statistical analysis The concentration of serum octreotide level will be realized with LCMS/MS following the method of Capron \& Wallemacq. Each blood sample should be taken 4 times per year just before the next injection of Octreotide LAR.

Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation

Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation A Prospective Interventional Trial of Patients With Neuro-endocrine Tumors With Carcinoid Syndrome Receiving Octreotide LAR

The primary endpoint is defined as follows:

* Treatment success: Symptom control is achieved within 2 years of treatment with octreotide LAR. Symptom control is defined as at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day.
* Treatment failure: No symptom control is achieved within 2 years of treatment with octreotide LAR.

The response rate will be calculated as the number of patients with treatment success divided by the total number of included patients that received at least one injection of octreotide LAR.

To describe the number of symptoms in correlation to the serum octreotide level, defined by a blood level test of octreotide.

To describe the rate of diarrhea and flushing via a patient diary

To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary).

To describe the effect of Octreotide LAR on Quality of Life, based on the change from baseline in the OLO-GINET21 scores

To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria

•

To describe the safety of octreotide (CTCAE grades)

To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sandostatin for Patients With Androgen Independent Prostate Cancer	NCT00510224	Prostate Cancer	Sandostatin	-	University of California, San Francisco
Stress, Diurnal Cortisol, and Breast Cancer Survival	NCT00226967	Breast Cancer	Sandostatin	35 Years -	Stanford University
Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers	NCT01121939	Neuroendocrine ...	Bevacizumab Pertuzumab Sandostatin LAR...	18 Years -	SCRI Development Innovations, LLC
Stress, Diurnal Cortisol, and Breast Cancer Survival	NCT00226967	Breast Cancer	Sandostatin	35 Years -	Stanford University
Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers	NCT01121939	Neuroendocrine ...	Bevacizumab Pertuzumab Sandostatin LAR...	18 Years -	SCRI Development Innovations, LLC
Stress, Diurnal Cortisol, and Breast Cancer Survival	NCT00226967	Breast Cancer	Sandostatin	35 Years -	Stanford University
Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation	NCT04140409	Neuroendocrine ... Carcinoid Syndr...	Sandostatin	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Spots Global Cancer Trial Database for sandostatin

Every month we try and update this database with for sandostatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sandostatin

Every month we try and update this database with for sandostatin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sandostatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.