NCT00005839: Oxaliplatin plus capecitabine: early dose study

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Completed

NCT00005839 was an early dose-finding study of oxaliplatin plus capecitabine for metastatic or recurrent solid tumors. The City of Hope/National Cancer Institute protocol was phase I, with dose-escalation cohorts designed to characterize toxicity and determine a tolerable combination dose. 1 2

The protocol projected 12–15 participants; that is not a verified actual enrollment or response denominator. Progression and survival were followed, but the main purpose was dose and safety characterization rather than a definitive comparison against standard treatment. The inspected historical record lists completion. 1 2

A verified maximum tolerated dose, dose-limiting-toxicity rate, and tumor-response estimate were not recovered from the inspected material. The study’s existence therefore does not establish that this combination improved survival in all of the different tumor types permitted by the protocol. 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00005839. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00005839. Original study registration: sponsor, design, population, endpoints and dated history.

2. ICH GCP — ICH GCP — readable reproduction of the sponsor-submitted ClinicalTrials.gov record. Supports the registration details quoted here; not an independent clinical-results publication.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.