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ACTIVE NOT RECRUITING Phase 2

Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas

NCT02595424 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 67 participants
Start Date 2016-04-06
Est. Completion 2029-01-01
Phase Phase 2

Sponsor

ECOG-ACRIN Cancer Research Group

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02595424

The ClinicalTrials.gov registry entry for NCT02595424 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02595424 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02595424?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial