Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01824875 · ClinicalTrials.gov registry record · Phase 2
Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors
A Phase 2 study of Insulinoma and Gastrinoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
- 20
- Study locations
NCT01824875: Active Phase 2 study of Insulinoma and Gastrinoma, sponsored by ECOG-ACRIN Cancer Research Group.
NCT01824875 is a Phase 2 study of Insulinoma and Gastrinoma that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 144 participants, below the 392-participant average among 5 other Insulinoma trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01824875, a Phase 2 study of Insulinoma and Gastrinoma, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG temozolomide
- DRUG capecitabine
Study Locations (20)
California
- Kaiser Anaheim Medical Center - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Kaiser Permanente Medical Group - Baldwin Park - Baldwin Park
- Kaiser Foundation Hospital - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills - Peninsula Hospitals - Burlingame
- Kaiser Permanente Hospital - Fontana
- Kaiser Permanente, Fremont - Fremont
- Kaiser Permanente - Fresno
- Kaiser Permanente - Harbor City - Harbor City
- Kaiser Permanente, Hayward - Hayward
- Southern California Permanente Medical Group - Irvine
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- University of Southern California/Norris Cancer Center - Los Angeles
- Kaiser Permanente-West Los Angeles - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Kaiser Permanente-Modesto - Modesto
- Sutter Cancer Research Consortium - Novato
- Kaiser Permanente-Oakland - Oakland
- University of California Medical Center At Irvine-Orange Campus - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2013-08-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT01824875 still lists
NCT01824875 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 392-participant average among 5 other Insulinoma trials with a reported enrollment target (63% lower).
The record links to 7 conditions, with Insulinoma appearing as the primary indexed condition, and to 2 interventions - of which temozolomide is the first listed.
NCT01824875 names 20 study sites across 1 states, led by California.
Frequently Asked Questions
What is clinical trial NCT01824875 about?
NCT01824875 is a clinical study titled "Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors". 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, eit...
What is the current status of trial NCT01824875?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2013-08-08. Estimated completion is 2026-12.
What conditions does trial NCT01824875 study?
This clinical trial studies the following conditions: Insulinoma, Gastrinoma, Glucagonoma, Pancreatic Polypeptide Tumor, Recurrent Islet Cell Carcinoma.
What interventions are being tested in trial NCT01824875?
The interventions under investigation include: temozolomide (DRUG), capecitabine (DRUG).
Who is sponsoring clinical trial NCT01824875?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01824875 being conducted?
This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insulinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
COMPLETED · Phase 2
-
Diagnosing and Treating Low Blood Sugar Levels
RECRUITING
-
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
RECRUITING · Phase 1
-
Everolimus and Vatalanib in Treating Patients With Advanced Solid Tumors
COMPLETED · Phase 1
-
Laparoscopy to Remove Pancreatic Tumors (Insulinomas)
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01861106 · 144 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations
- NCT03482245 · 144 participants · NA
The Role of Circadian Clock Proteins in Innate and Adaptive Immunity
- NCT03504683 · 144 participants · NA
MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
- NCT03905603 · 144 participants · Early Phase 1
Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI