CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 67 enrolled
Drug / intervention
Capecitabine +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02595424
NCT02595424Phase 2Active

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

ECOG-ACRIN Cancer Research Group·interventional·Posted Nov 3, 2015·Updated May 1, 2026

In Brief

A Phase 2 clinical trial evaluating Capecitabine, Carboplatin, and 4 other interventions for Gastric Neuroendocrine Carcinoma and 2 related conditions. Active but no longer recruiting, targeting 67 participants across 673 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2Active
20162017201820192020202120222023202420252026202720282029
First PostedNov 3, 2015
Enrollment StartNov 6, 2015
Primary CompletionApr 23, 2025
Study CompletionJan 1, 2029
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 10.7 years ago

Interventions

Capecitabinedrug

Given PO

Carboplatindrug

Given IV

Cisplatindrug

Given IV

Etoposidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Temozolomidedrug

Given PO