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  • Cancer Type: Gastrointestinal Tumor
  • Study Type: Treatment
  • NCT#: NCT05040360
  • Phase: Phase II
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  • Overview

    Study Title:

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


    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(s) a. 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 Objective(s) a. To evaluate overall survival (OS) in participants randomized to treatment with CAPTEM compared to observation only. b. To evaluate the safety and tolerability of CAPTEM compared to observation only. Banking Objectives a. To bank specimens for future correlative studies.

  • Treatments


    Chemotherapy (NOS); Observational


    Standard of Care (); Temodal (Temozolomide); Temozolomide (); Xeloda (capecitabine); capecitabine ()

  • Inclusion Criteria

      Inclusion Criteria:
    • Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 90 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease unless liver oligometastatic disease was deemed to be resected/ablated at time of sugery. Acceptable scans are multiphase CT abdomen, MRI with IV contrast of the abdomen, or multiphasic CT of the abdoment should include arterial-phase imaging of the liver in addition to the portal venous phase.
    • Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report
    • Participants must have Ki-67 testing performed from the surgical specimen collected between 14 and 90 days prior to registration. The Ki-67 result must be >/=3% and > Participants with localized resected pNETS must have a Zaidi score of >= 3 derived by the factors and points as outlined in protocol.
    • Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection
    • Participants must have recovered from effects of surgery as determined by the treating investigator
    • Participants must be 18 years of age or older
    • Participants must have Zubrod performance status of 0-2
    • Participants must have a complete medical history and physical exam within 28 days prior to registration
    • Adequate organ function as outlined in protocol
    • Participants must be able to swallow pills
    • Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol
    • No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years
    • Other criteria may apply
  • Exclusion Criteria

      Exclusion Criteria:
    • Participants must not have unresected or unablated metastatic disease
    • Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis
    • Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted
    • Participants must not have received somatostatin analogs after surgery
    • Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed
    • Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
    • Participants must not have known absorption issues that would limit the ability to absorb study agents
    • Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration
    • Participants must not have active or uncontrolled infection
    • Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator
    • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
    • Other criteria may apply

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