Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

NCT ID: NCT00227773

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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.

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.

Conditions

Gastrointestinal Carcinoid Tumor; Islet Cell Carcinoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

octreotide acetate

Intervention Type: DRUG

vatalanib

Intervention Type: DRUG

anti-cytokine therapy

Intervention Type: PROCEDURE

antiangiogenesis therapy

Intervention Type: PROCEDURE

biological therapy

Intervention Type: PROCEDURE

endocrine therapy

Intervention Type: PROCEDURE

enzyme inhibitor therapy

Intervention Type: PROCEDURE

growth factor antagonist therapy

Intervention Type: PROCEDURE

hormone therapy

Intervention Type: PROCEDURE

protein tyrosine kinase inhibitor therapy

Intervention Type: PROCEDURE

somatostatin analogue therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Kyle Holen, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Mary Mulcahy, MD

Role:

Robert H. Lurie Cancer Center

Other Identifiers

ECOG-E6203

Identifier Type: -

Identifier Source: secondary_id

CDR0000446076

Identifier Type: -

Identifier Source: org_study_id