Vatalanib And Octreotide In Treating Patients With Progressive Neuroendocrine Tumors

Study Overview

Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

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.

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.

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

CDR0000446076
ECOG-E6203

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-09-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-10-06
First Submitted that Met QC Criteria 2005-09-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-10-08
First Posted (ESTIMATED) 2005-09-28	Results First Posted N/A	Last Verified 2015-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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%

18 and over

ECOG 0-2

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 medication

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Kyle Holen, MD, University of Wisconsin, Madison

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record