Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02595424 · ClinicalTrials.gov registry record · Phase 2
Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
A Phase 2 study of Pancreatic Neuroendocrine Carcinoma and Gastric Neuroendocrine Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 20
- Study locations
NCT02595424: Active Phase 2 study of Pancreatic Neuroendocrine Carcinoma and Gastric Neuroendocrine Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
NCT02595424 is a Phase 2 study of Pancreatic Neuroendocrine Carcinoma and Gastric Neuroendocrine Carcinoma that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 67 participants, below the 5,263-participant average among 4 other Pancreatic Neuroendocrine Carcinoma trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02595424, a Phase 2 study of Pancreatic Neuroendocrine Carcinoma and Gastric Neuroendocrine Carcinoma, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, 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. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
Primary Outcome
PFS is defined as the time from randomization to documented progression or death without progression. PFS is censored at the date of last disease evaluation. The study was closed for futility in 2021 after the 2021 Spring DSMC meeting, which found that the boundary for futility had been met (ie, temozolomide and capecitabine did not appear to be superior to platinum and etoposide chemotherapy). As the interim analysis finding led to the conclusion of the study, no PFS stratified logrank test was
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Capecitabine
- DRUG Cisplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Etoposide
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills-Peninsula Medical Center - Burlingame
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Eden Hospital Medical Center - Castro Valley
- Sutter Davis Hospital - Davis
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Palo Alto Medical Foundation-Fremont - Fremont
- Kaiser Permanente-Fresno - Fresno
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2016-04-06 |
| Est. Completion | 2029-01-01 |
| Phase | Phase 2 |
What the registry record for NCT02595424 still lists
NCT02595424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 5,263-participant average among 4 other Pancreatic Neuroendocrine Carcinoma trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Pancreatic Neuroendocrine Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT02595424 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02595424 about?
NCT02595424 is a clinical study titled "Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas". This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metas...
What is the current status of trial NCT02595424?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2016-04-06. Estimated completion is 2029-01-01.
What conditions does trial NCT02595424 study?
This clinical trial studies the following conditions: Pancreatic Neuroendocrine Carcinoma, Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma.
What interventions are being tested in trial NCT02595424?
The interventions under investigation include: Carboplatin (DRUG), Capecitabine (DRUG), Cisplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Etoposide (DRUG).
Who is sponsoring clinical trial NCT02595424?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02595424 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pancreatic Neuroendocrine Carcinoma
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.
-
Multicenter Trial of ESK981 in Patients With Select Solid Tumors
RECRUITING · Phase 2
-
Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
RECRUITING
-
Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"
RECRUITING · NA
-
Assessment of What Patients and Healthcare Providers Value
COMPLETED
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
- NCT03213002 · 67 participants · Phase 1
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
- NCT04115163 · 67 participants · Phase 2
Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
- NCT04315324 · 67 participants · Phase 1
Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)
- NCT04532424 · 67 participants · NA
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
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