Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors
This study has been withdrawn prior to recruitment.
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 symptoms, such as diarrhea, caused by 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 acetate
Drug: vatalanib
Procedure: anti-cytokine therapy
Procedure: antiangiogenesis therapy
Procedure: biological 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 Carcinoid Tumors
Drug Information available for: Vatalanib Butanedioic acid, compd. with N-(4-chlorophenyl)-4-(4-pyridinylmethyl)-1-phthalazinamine (1:1) Octreotide Octreotide acetate Tyrosine Somatostatin
U.S. FDA Resources
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):

Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227773

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Kyle Holen, MD University of Wisconsin, Madison
Investigator: Mary Mulcahy, MD Robert H. Lurie Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000446076, ECOG-E6203
Study First Received: September 26, 2005
Last Updated: October 24, 2006
ClinicalTrials.gov Identifier: NCT00227773  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized gastrointestinal carcinoid tumor
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor
recurrent islet cell carcinoma
gastrinoma
insulinoma
WDHA syndrome
glucagonoma
pancreatic polypeptide tumor
somatostatinoma

Study placed in the following topic categories:
Gastrointestinal Diseases
Pancreatic Neoplasms
Pancreatic Polypeptide
Octreotide
Vatalanib
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Endocrine Gland Neoplasms
Digestive System Neoplasms
Carcinoma, Islet Cell
Serotonin Syndrome
Insulinoma
Endocrine System Diseases
Malignant Carcinoid Syndrome
Carcinoid syndrome
Somatostatin
Recurrence
Neuroendocrine Tumors
Carcinoma
Carcinoid tumor
Neuroectodermal Tumors
Gastrinoma
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoid Tumor
Endocrinopathy
Adenocarcinoma
Pancreatic islet cell tumors
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Hormones
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009