NCT01824875|Active Not RecruitingPhase 2ResultsDMCFDA Drug

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

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

ECOG-ACRIN Cancer Research Group ClinicalTrials.gov

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4 other identifiers

E2211NCI-2012-02007U10CA021115U10CA180820

Study Type

interventional

Target

144

Locations

1 country

Sites

323

Timeline

RegisteredApr 2013

StartedAug 2013

CompletionDec 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

144

participants targeted

Target at P75+ for phase_2

Timeline

7mo left

Started Aug 2013

Longer than P75 for phase_2

Geographic Reach

1 country

323 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

13.3 years study duration

Study Progress96%

Aug 2013Dec 2026

First Submitted

Initial submission to the registry

April 2, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed

4 months until next milestone

Study Start

First participant enrolled

August 8, 2013

Completed

7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2021

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

October 19, 2022

Completed

4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

7.8 years

First QC Date

April 2, 2013

Results QC Date

September 16, 2022

Last Update Submit

February 6, 2026

Conditions

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

Keywords

temozolomidecapecitabinepancreatic neuroendocrine tumor

Outcome Measures

Primary Outcomes (1)

Progression-free Survival
Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier method was used to estimate PFS.
Assessed every 3 months for 3 years and then every 6 months for years 3-5

Secondary Outcomes (4)

Proportion of Patients With Response
Assessed every 3 months for 3 years and then every 6 months for years 3-5
Overall Survival
Assessed every 3 months for 3 years and then every 6 months for years 3-5
Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response
Assessed every 3 months for 3 years and then every 6 months for years 3-5
Association Between Methyl Guanine Methyltransferase (MGMT) Status by Promoter Methylation and Response
Assessed every 3 months for 3 years and then every 6 months for years 3-5

Study Arms (2)

Arm A (temozolomide)

EXPERIMENTAL

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.

Drug: temozolomide

Arm B (temozolomide and capecitabine)

EXPERIMENTAL

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.

Drug: temozolomideDrug: capecitabine

Interventions

temozolomideDRUG

Given PO

Also known as: Temodar

Arm A (temozolomide)Arm B (temozolomide and capecitabine)

capecitabineDRUG

Given PO

Also known as: Xeloda

Arm B (temozolomide and capecitabine)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)
+9 more criteria

You may not qualify if:

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
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

ECOG-ACRIN Cancer Research Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (323)

Kaiser Anaheim Medical Center

Anaheim, California, 92807, United States

Location

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

Location

Kaiser Permanente Medical Group - Baldwin Park

Baldwin Park, California, 91706, United States

Location

Kaiser Foundation Hospital

Bellflower, California, 90706, United States

Location

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

Mills - Peninsula Hospitals

Burlingame, California, 94010, United States

Location

Kaiser Permanente Hospital

Fontana, California, 92335, United States

Location

Kaiser Permanente, Fremont

Fremont, California, 94538, United States

Location

Kaiser Permanente

Fresno, California, 93720, United States

Location

Kaiser Permanente - Harbor City

Harbor City, California, 90710, United States

Location

Kaiser Permanente, Hayward

Hayward, California, 94545, United States

Location

Southern California Permanente Medical Group

Irvine, California, 92618, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

University of Southern California/Norris Cancer Center

Los Angeles, California, 90033, United States

Location

Kaiser Permanente-West Los Angeles

Los Angeles, California, 90034, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

Location

Sutter Cancer Research Consortium

Novato, California, 94945, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

University of California Medical Center At Irvine-Orange Campus

Orange, California, 92868, United States

Location

Kaiser Permanente - Panorama City

Panorama City, California, 91402, United States

Location

Kaiser Permanente-Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente Medical Center

Riverside, California, 92505, United States

Location

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

Location

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser Permanente - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente at San Diego

San Diego, California, 92120, United States

Location

Kaiser Permanente

San Diego, California, 92120, United States

Location

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

Location

UCSF-Mount Zion

San Francisco, California, 94115, United States

Location

California Pacific Medical Center

San Francisco, California, 94118, United States

Location

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente Health Care

San Marcos, California, 92069, United States

Location

Kaiser Permanente-San Rafael

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

Location

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

Location

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

Location

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Sutter Solano Medical Center

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

Kaiser Permanente

Woodland Hills, California, 91367, United States

Location

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Middlesex Hospital

Middletown, Connecticut, 06457, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Gynecologic Oncology LLC