Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor

Summary

This phase I trial studies the side effects and best dose of veliparib when given together with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has spread to other places in the body and usually cannot be cured or controlled with treatment, has returned after a period of improvement, and cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Conditions

• Functional Pancreatic Neuroendocrine Tumor
• Malignant Somatostatinoma
• Merkel Cell Carcinoma
• Metastatic Adrenal Gland Pheochromocytoma
• Metastatic Carcinoid Tumor
• Multiple Endocrine Neoplasia Type 1
• Multiple Endocrine Neoplasia Type 2A
• Multiple Endocrine Neoplasia Type 2B
• Neuroendocrine Neoplasm
• Non-Functional Pancreatic Neuroendocrine Tumor
• Pancreatic Glucagonoma
• Pancreatic Insulinoma
• Recurrent Adrenal Cortex Carcinoma
• Recurrent Adrenal Gland Pheochromocytoma
• Recurrent Merkel Cell Carcinoma
• Somatostatin-Producing Neuroendocrine Tumor
• Stage III Adrenal Cortex Carcinoma
• Stage III Thyroid Gland Medullary Carcinoma
• Stage IIIA Merkel Cell Carcinoma
• Stage IIIB Merkel Cell Carcinoma
• Stage IV Adrenal Cortex Carcinoma
• Stage IV Merkel Cell Carcinoma
• Stage IVA Thyroid Gland Medullary Carcinoma
• Stage IVB Thyroid Gland Medullary Carcinoma
• Stage IVC Thyroid Gland Medullary Carcinoma
• Thymic Carcinoid Tumor
• VIP-Producing Neuroendocrine Tumor
• Well Differentiated Adrenal Cortex Carcinoma
• Zollinger Ellison Syndrome

Interventions

DRUG

Capecitabine

Given PO

DRUG

Temozolomide

Given PI

DRUG

Veliparib

given PO

OTHER

Pharmacological Study

Correlative studies

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Jordan Berlin, M.D. · Vanderbilt-Ingram Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-31

Primary Completion

2019-02-28

Completion

2020-02-29

FDA Drug

Yes