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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

Description

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

Details

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

Keywords

Gastrinoma Glucagonoma Insulinoma Islet Cell Carcinoma Pancreatic Polypeptide Tumor Recurrent Islet Cell Carcinoma Somatostatinoma Capecitabine Temozolomide Dacarbazine

Eligibility

For people ages 18 years and up

Inclusion Criteria:

  • Patient must have histologically or pathologically confirmed locally unresectable or metastatic low or intermediate grade pancreatic neuroendocrine tumor, excluding small cell carcinoma
  • 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 =< 12 months from date of randomization
  • Patient must not have received prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapy
  • 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 stable doses for 8 weeks and
  • Have documented disease progression on that dose
  • Patients may not be receiving any other investigational agents while on study treatment
  • Patients may not be receiving Coumadin while on treatment; other anticoagulants are allowed
  • Leukocytes >= 3,000/mm3

  • Absolute neutrophil count >= 1,500/mm3

  • Hemoglobin >= 9 g/dL
  • Platelets >= 100,000/mm3

  • 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
  • Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis are ineligible
  • Patients must NOT have active or uncontrolled infection or serious medical or psychiatric illness
  • Patients must NOT have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
  • Patient must NOT have absorption issues that would limit the ability to absorb study agents
  • Patients with a history of the following within =< 12 months of study entry are not eligible:
  • Arterial thromboembolic events
  • Unstable angina
  • Myocardial Infarction
  • Patients with symptomatic peripheral vascular disease are not eligible
  • Patients must NOT have 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
  • Women must not be pregnant or breast-feeding; 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

Locations

  • Kaiser Permanente-San Francisco
    San Francisco, California, 94115, United States
  • California Pacific Medical Center
    San Francisco, California, 94118, United States
  • Kaiser Permanente
    Fresno, California, 93720, United States
  • Kaiser Permanente-South San Francisco
    South San Francisco, California, 94080, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California, 94704, United States
  • Kaiser Permanente-Richmond
    Richmond, California, 94801, United States
  • Mills - Peninsula Hospitals
    Burlingame, California, 94010, United States
  • Kaiser Permanente-Oakland
    Oakland, California, 94611, United States
  • Kaiser Permanente-San Rafael
    San Rafael, California, 94903, United States
  • Kaiser Permanente, Hayward
    Hayward, California, 94545, United States
  • Kaiser Permanente-Redwood City
    Redwood City, California, 94063, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California, 94596, United States
  • Sutter Cancer Research Consortium
    Novato, California, 94945, United States
  • Stanford University Hospitals and Clinics
    Stanford, California, 94305, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California, 94589, United States
  • Sutter Solano Medical Center
    Vallejo, California, 94589, United States
  • Kaiser Permanente, Fremont
    Fremont, California, 94538, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California, 95051, United States
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California, 94531, United States
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California, 95688, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California, 95119, United States
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California, 95403, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California, 95403, United States
  • Kaiser Permanente-Stockton
    Stockton, California, 95210, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California, 95823, United States
  • Kaiser Permanente-Modesto
    Modesto, California, 95356, United States
  • Kaiser Permanente - Sacramento
    Sacramento, California, 95825, United States
  • Kaiser Permanente-Roseville
    Roseville, California, 95661, United States
  • Kaiser Permanente - Panorama City
    Panorama City, California, 91402, United States
  • Kaiser Permanente
    Woodland Hills, California, 91367, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California, 90027, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California, 90048, United States
  • Kaiser Permanente-West Los Angeles
    Los Angeles, California, 90034, United States
  • University of Southern California/Norris Cancer Center
    Los Angeles, California, 90033, United States
  • Kaiser Permanente Medical Group - Baldwin Park
    Baldwin Park, California, 91706, United States
  • Kaiser Foundation Hospital
    Bellflower, California, 90706, United States
  • Kaiser Permanente - Harbor City
    Harbor City, California, 90710, United States
  • Kaiser Permanente Hospital
    Fontana, California, 92335, United States
  • Kaiser Anaheim Medical Center
    Anaheim, California, 92807, United States
  • University of California Medical Center At Irvine-Orange Campus
    Orange, California, 92868, United States
  • Kaiser Permanente Medical Center
    Riverside, California, 92505, United States
  • Southern California Permanente Medical Group
    Irvine, California, 92618, United States
  • Nevada Cancer Research Foundation CCOP
    Las Vegas, Nevada, 89106, United States
  • Kaiser Permanente Health Care
    San Marcos, California, 92069, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Eastern Cooperative Oncology Group
ID
NCT01824875
Phase
Phase 2
Lead Scientist
Emily Bergsland
Study Type
Interventional
Last Updated
March 2016