Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Neuroendocrine Tumors

Adenoma

Adenoma, Islet Cell

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Glandular and Epithelial

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Temozolomide

Antimetabolites

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO once QD on days 10-14. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo surveillance with no active treatment.

Site Public Contact

Charles W. Drescher

Shahzad Siddique

Timothy J. Hobday

Junaid Arshad

Jay W. Carlson

Syma Iqbal

Jennifer B. Valerin

Pamela L. Kunz

Peter J. Hosein

Paul M. Bloomston

Brian H. Ramnaraign

Jonathan R. Strosberg

Mihir M. Shah

Tanmay Sahai

Mary F. Mulcahy

Chih-Yi Liao

Joseph J. Merchant

Heloisa P Soares

This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, 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. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.

PRIMARY OBJECTIVE:

I. To evaluate recurrence-free survival (RFS) in participants with resected pancreatic neuroendocrine tumors (pNETs) randomized to treatment with capecitabine + temozolomide (CAPTEM) compared to observation only.

SECONDARY OBJECTIVES:

I. To evaluate overall survival (OS) in participants randomized to treatment with CAPTEM compared to observation only.

II. To evaluate the safety and tolerability of CAPTEM compared to observation only.

BANKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14 and temozolomide PO once daily (QD) on days 10-14. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo surveillance with no active treatment.

After completion of study treatment, patients are followed up every 6 months for 3 years and then annually until 5 years from randomization.

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors

Distribution of RFS in each arm will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.

Distribution of OS in each arm will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.

Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

National Cancer Institute (NCI)

SWOG Cancer Research Network

Spots Global Cancer Trial Database for stage i pancreatic neuroendocrine tumor ajcc v8