Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00227773
First received: September 26, 2005
Last updated: October 24, 2006
Last verified: October 2006
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00227773     History of Changes
Other Study ID Numbers: CDR0000446076, ECOG-E6203
Study First Received: September 26, 2005
Last Updated: October 24, 2006
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

Additional relevant MeSH terms:
Carcinoid Tumor
Carcinoma
Neuroendocrine Tumors
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Carcinoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Enzyme Inhibitors
Vatalanib
Mitogens
Hormones
Somatostatin
Octreotide
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Mitosis Modulators

ClinicalTrials.gov processed this record on August 26, 2014