Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT01824875 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 6 more changesShow less
    • Study completion date changed from estimate of Dec 2026 to May 26, 2026
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Study description revised
    • Site details revised at 13 of 323 sites
    • Publications: details revised at 1 of 1 entry
  2. Study completion date: Dec 2025 to Dec 2026v19
  3. Study completion date: Dec 2024 to Dec 2025v18
  4. Study completion date: Jan 2024 to Dec 2024v17
  5. Study completion date: Jul 2023 to Jan 2024v16
Show 14 earlier versionsHide 14 earlier versions
  1. Start date: Apr 11, 2013 to Aug 8, 2013v15
  2. Lead sponsor: Eastern Cooperative Oncology Group to ECOG-ACRIN Cancer Research Groupv14 Show 6 more changesShow less
    • Results first posted: Oct 19, 2022
    • Primary endpoint revised
    • Enrollment target: 145 to 144
    • Interventions: capecitabine (Drug), laboratory biomarker analysis (Other), temozolomide (Drug) to capecitabine (Drug), temozolomide (Drug)
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: 3 to 4
  3. Primary completion date changed from estimate of Aug 1, 2021 to May 26, 2021v13
  4. Primary completion date: Mar 1, 2021 to Aug 1, 2021v12
  5. Primary completion date: Jun 1, 2023 to Mar 1, 2021v11
  6. Primary completion date: Jun 1, 2019 to Jun 1, 2023v10
  7. Primary completion date: Jul 2018 to Jun 1, 2019v9
  8. Primary completion date: Jul 2017 to Jul 2018
    • Study completion date: Jul 2023
    • Start date: May 2013 to Apr 11, 2013
    v8
  9. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 325 to 323
    v7
  10. Primary completion date: Dec 2014 to Jul 2017
    • Study sites: 324 to 325
    v6
  11. Study sites: 1 to 324
    • Start date: Apr 2013 to May 2013
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints revised (3)
    v5
  12. Re-verified, no change to tracked fieldsv4
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2012 to Apr 2013
    • Site details revised
    v3
  14. Eligibility criteria expanded, about 3 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT01824875
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Gastrinoma, Glucagonoma, Insulinoma, Islet Cell Carcinoma, Pancreatic Polypeptide Tumor, Recurrent Islet Cell Carcinoma, Somatostatinoma
Related terms Adenoma, Islet Cell, Carcinoma, Islet Cell, Gastrinoma, Glucagonoma, Insulinoma, Somatostatinoma
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov