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ACTIVE NOT RECRUITING

NCT01824875

PHASE2

Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

Summary

This randomized phase II trial studies how well giving temozolomide with or without capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs used in chemotherapy, such as temozolomide and capecitabine, 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. It is not yet known whether temozolomide is more effective with or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.

Official title: A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2013-08-08

Completion Date

2026-12

Last Updated

2026-02-25

Healthy Volunteers

Conditions

Gastrinoma Glucagonoma Insulinoma Islet Cell Carcinoma Pancreatic Polypeptide Tumor Recurrent Islet Cell Carcinoma Somatostatinoma

Interventions

DRUG

temozolomide

Given PO

DRUG

capecitabine

Given PO

Inclusion Criteria: * Patient must have histologically or pathologically confirmed locally unresectable or metastatic low or intermediate grade pancreatic neuroendocrine tumor * Patient must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained \<= 4 weeks prior to randomization and must be acquired by multiphasic CT or contrast magnetic resonance imaging (MRI) * Date of last documented disease progression must be within 12 months from date of randomization * Prior everolimus and/or sunitinib therapy is allowed, so long as it was discontinued \>= 4 weeks prior to randomization * Concurrent somatostatin analogues are allowed provided that patients * Have been on a stable dose for 8 weeks and * Have documented disease progression on that dose * Chemoembolization is allowed if ≥ 4 weeks from study entry. There are 2 possible scenarios: * If patient has hepatic disease only: they need to have progressed in the liver since chemoembolization and have measurable disease by RECIST 1.1 in order to be eligible. * If patient has hepatic and extrahepatic disease: they will need to have progressed inside OR outside the liver and have measureable disease by RECIST 1.1 in order to be eligible. * Leukocytes \>= 3,000/mm\^3 * Absolute neutrophil count \>= 1,500/mm\^3 * Hemoglobin \>= 9 g/dL * Platelets \>= 100,000/mm\^3 * Total bilirubin \<= institutional upper limit of normal (ULN) or \<= 1.5 X institutional ULN (if the patient has liver metastases) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \<= 3 X institutional ULN or (\<= 5 X institutional ULN if the patient has liver metastases) * Serum creatinine \<= 1.5 X institutional ULN * Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patient must have life expectancy \>= 12 weeks all females of childbearing potential must have a blood test or urine study within =\< 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately * Patient must be able to swallow pills * Patient must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol Exclusion Criteria: * Small cell carcinoma * Prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapy * Receiving any other investigational agents while on study treatment * Receiving Coumadin while on treatment; other anticoagulants are allowed * Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis are ineligible * Active or uncontrolled infection or serious medical or psychiatric illness * History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine * Absorption issues that would limit the ability to absorb study agents * Patients with a history of the following within 12 months of study entry: * Arterial thromboembolic events * Unstable angina * Myocardial Infarction * Symptomatic peripheral vascular disease * Patients with previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions: * Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ OR * Prior malignancy completely excised or removed and patient has been continuously disease free for \> 5 years OR * Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for \> 5 years * Pregnant or breast-feeding

Locations (323)

Kaiser Anaheim Medical Center

Anaheim, California, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Kaiser Permanente Medical Group - Baldwin Park

Baldwin Park, California, United States

Kaiser Foundation Hospital

Bellflower, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Mills - Peninsula Hospitals

Burlingame, California, United States

Kaiser Permanente Hospital

Fontana, California, United States

Kaiser Permanente, Fremont

Fremont, California, United States

Kaiser Permanente

Fresno, California, United States

Kaiser Permanente - Harbor City

Harbor City, California, United States

Kaiser Permanente, Hayward

Hayward, California, United States

Southern California Permanente Medical Group

Irvine, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

University of Southern California/Norris Cancer Center

Los Angeles, California, United States

Kaiser Permanente-West Los Angeles

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

University of California Medical Center At Irvine-Orange Campus

Orange, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente Medical Center

Riverside, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente - Sacramento

Sacramento, California, United States

Kaiser Permanente at San Diego

San Diego, California, United States

Kaiser Permanente

San Diego, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

UCSF-Mount Zion

San Francisco, California, United States

California Pacific Medical Center

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente Health Care

San Marcos, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Stanford University Hospitals and Clinics

Stanford, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Sutter Solano Medical Center

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Kaiser Permanente

Woodland Hills, California, United States

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Middlesex Hospital

Middletown, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Gynecologic Oncology LLC

Newark, Delaware, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Regional Hematology and Oncology PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Nanticoke Memorial Hospital

Seaford, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Edna Williams Cancer Center at the Baptist Cancer Institute

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Oncare Hawaii Inc-POB II