Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00227773

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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