GoldBamboo.com - Knowledge is strong medicine
  

Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors - Article


  Not Signed In - Sign In / Register






Carcinoid Tumor,Gastrointestinal


Clinical Trial: Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) September 2005

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00227773

Purpose

RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control the symptoms from the tumor. Giving vatalanib together with octreotide may be an effective treatment for neuroendocrine tumors.

PURPOSE: This phase II trial is studying how well giving vatalanib together with octreotide works in treating patients with progressive neuroendocrine tumors.

Condition Intervention Phase
Gastrointestinal Carcinoid Tumor
Islet Cell Carcinoma
 Drug: octreotide
 Drug: vatalanib
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: endocrine therapy
 Procedure: enzyme inhibitor therapy
 Procedure: growth factor antagonist therapy
 Procedure: hormone therapy
 Procedure: protein tyrosine kinase inhibitor therapy
 Procedure: somatostatin analogue therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapies;   Carcinoid Tumors;   Digestive Diseases;   Pancreatic Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors

Further study details as provided by National Cancer Institute (NCI):

OBJECTIVES:

  • Determine the 4-month progression-free and overall survival of patients with progressive low-grade neuroendocrine tumors treated with vatalanib and octreotide.
  • Determine the response rate in patients treated with this regimen.
  • Determine the effect of this regimen on tumor markers (e.g., chromogranin A, 5-HIAA, and gastrin) in these patients.
  • Determine the toxicity and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral vatalanib once daily on days 1- 28 and octreotide* intramuscularly or IV on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients on a stable dose (i.e., no changes in dosage within the past 3 months) of octreotide before study entry remain on their current dose and schedule during study participation; patients who experience hypersensitivity and/or toxicity to octreotide may receive vatalanib alone.

After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed low-grade neuroendocrine tumors
  • The following tumor types are excluded:
  • Small cell lung cancer
  • Medullary thyroid cancer
  • Paraganglioma
  • Pheochromocytoma
  • Measurable disease
  • Radiographic evidence of disease progression after completion of any prior systemic therapy, chemoembolization, bland embolization, or observation within the past year, defined as either of the following:
  • Appearance of a new lesion
  • At least 20% increase in the longest diameter (LD) of any previously documented lesion or an increase in the sum of the LDs of multiple lesions in the aggregate of 20%

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL

Hepatic

  • Bilirubin ≤ 2.0 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN (5 times ULN if liver metastases are present)

Renal

  • Creatinine ≤ 1.5 times ULN
  • Meets 1 of the following criteria:
  • Urine protein negative by dipstick
  • Urine protein:creatinine ratio < 1.0
  • Urine protein < 1 g by 24-hour urine collection

Gastrointestinal

  • Must be able to swallow tablets
  • No ulcerative disease
  • No uncontrolled nausea, vomiting, or diarrhea
  • No bowel obstruction
  • No other gastrointestinal tract disease resulting in an inability to take oral medication

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be able to receive a contrast-enhanced CT scan
  • No known history of allergic reaction to vatalanib or its derivatives or octreotide injections

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy
  • No more than 1 prior systemic chemotherapy regimen
  • Chemoembolization is not considered systemic chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • At least 4 weeks since prior major surgery

Other

  • At least 4 weeks since other prior systemic therapy
  • At least 4 weeks since prior local liver therapy
  • No prior anti-vascular endothelial growth factor agents
  • No concurrent grapefruit or grapefruit juice
  • No concurrent therapeutic warfarin or similar oral anticoagulants that are metabolized by the cytochrome P450 system
  • Concurrent heparin allowed

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00227773


Study chairs or principal investigators

Kyle Holen, MD,  Study Chair,  University of Wisconsin   
Mary Mulcahy, MD,  Robert H. Lurie Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000446076; ECOG-E6203
Last Updated:  December 8, 2005
Record first received:  September 26, 2005
ClinicalTrials.gov Identifier:  NCT00227773
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10


Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $50 a year, a savings of 50% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Carcinoid Tumor,Gastrointestinal.

October 8, 2008



Page Updated: September 23, 2004
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Massachusetts Law | Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Google Co-op | Health Forums

Copyright © 2004-2008 - Gold Bamboo LLC
All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.