Home
Clinical Trials
Temozolomide With or Without ...

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

Last Updated: 2025-02-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-08

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05040360

Metastatic Malignant Neoplasm in the Liver Pancreatic Neuroendocrine Tumor Stage I Pancreatic Neuroendocrine Tumor AJCC v8 +2 more

RECRUITING PHASE2

Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery

NCT01465659

Pancreatic Alpha Cell Carcinoma Pancreatic Beta Islet Cell Carcinoma Pancreatic Delta Cell Carcinoma +2 more

COMPLETED PHASE1/PHASE2

Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas

NCT02595424

Gastric Neuroendocrine Carcinoma Intestinal Neuroendocrine Carcinoma Pancreatic Neuroendocrine Carcinoma

ACTIVE_NOT_RECRUITING PHASE2

Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors

NCT05247905

Metastatic Pancreatic Neuroendocrine Tumor Unresectable Pancreatic Neuroendocrine Carcinoma

ACTIVE_NOT_RECRUITING PHASE2

Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors

NCT01525082

Gastrinoma Glucagonoma Insulinoma +6 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To evaluate progression-free survival (PFS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors.

SECONDARY OBJECTIVES:

I. To evaluate response rates (RR) associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.

II. To evaluate overall survival (OS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors.

III. To evaluate the toxicity associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.

IV. To evaluate the usefulness of methyl guanine methyltransferase (MGMT) status (by immunohistochemistry \[IHC\] and promoter methylation) for predicting response in pancreatic neuroendocrine tumor patients treated with either temozolomide or temozolomide and capecitabine.

V. To bank radiology images for evaluation of quality, reproducibility, and compliance with computed tomography (CT) methodology.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A (temozolomide)

Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

temozolomide

Intervention Type DRUG

Given PO

Arm B (temozolomide and capecitabine)

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

temozolomide

Intervention Type DRUG

Given PO

capecitabine

Intervention Type DRUG

Given PO

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

temozolomide

Given PO

Intervention Type DRUG

capecitabine

Given PO

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Temodar Xeloda

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pamela Kunz

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaiser Anaheim Medical Center

Anaheim, California, United States

Site Status

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Site Status

Kaiser Permanente Medical Group - Baldwin Park

Baldwin Park, California, United States

Site Status

Kaiser Foundation Hospital

Bellflower, California, United States

Site Status

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status

Mills - Peninsula Hospitals

Burlingame, California, United States

Site Status

Kaiser Permanente Hospital

Fontana, California, United States

Site Status

Kaiser Permanente, Fremont

Fremont, California, United States

Site Status

Kaiser Permanente

Fresno, California, United States

Site Status

Kaiser Permanente - Harbor City

Harbor City, California, United States

Site Status

Kaiser Permanente, Hayward

Hayward, California, United States

Site Status

Southern California Permanente Medical Group

Irvine, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

University of Southern California/Norris Cancer Center

Los Angeles, California, United States

Site Status

Kaiser Permanente-West Los Angeles

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente-Modesto

Modesto, California, United States

Site Status

Sutter Cancer Research Consortium

Novato, California, United States

Site Status

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status

University of California Medical Center At Irvine-Orange Campus

Orange, California, United States

Site Status

Kaiser Permanente - Panorama City

Panorama City, California, United States

Site Status

Kaiser Permanente-Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente-Richmond

Richmond, California, United States

Site Status

Kaiser Permanente Medical Center

Riverside, California, United States

Site Status

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente at San Diego

San Diego, California, United States

Site Status

Kaiser Permanente

San Diego, California, United States

Site Status

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status

UCSF-Mount Zion

San Francisco, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status

Kaiser Permanente Health Care

San Marcos, California, United States

Site Status

Kaiser Permanente-San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Site Status

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status

Stanford University Hospitals and Clinics

Stanford, California, United States

Site Status

Kaiser Permanente-Stockton

Stockton, California, United States

Site Status

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status

Sutter Solano Medical Center

Vallejo, California, United States

Site Status

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Site Status

Kaiser Permanente

Woodland Hills, California, United States

Site Status

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Middlesex Hospital

Middletown, Connecticut, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Gynecologic Oncology LLC

Newark, Delaware, United States

Site Status

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Regional Hematology and Oncology PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status

Nanticoke Memorial Hospital

Seaford, Delaware, United States

Site Status

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status

Edna Williams Cancer Center at the Baptist Cancer Institute

Jacksonville, Florida, United States

Site Status

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status