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

Phase 2
18 Years
Not Enrolling
Gastrointestinal Carcinoid Tumor, Islet Cell Carcinoma

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Trial Information

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


- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 8.0 g/dL


- Bilirubin ≤ 2.0 times upper limit of normal (ULN)

- AST ≤ 3 times ULN (5 times ULN if liver metastases are present)


- 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


- 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


- 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


Biologic therapy

- Not specified


- 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


- At least 3 weeks since prior radiotherapy

- No concurrent radiotherapy


- At least 4 weeks since prior major surgery


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kyle Holen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Carcinoma
  • 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
  • Carcinoid Tumor
  • Carcinoma
  • Neuroendocrine Tumors
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Carcinoma, Islet Cell