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NCT00869050 · ClinicalTrials.gov registry record · Phase 2

Capecitabine and Temozolomide for Neuroendocrine Cancers

A Phase 2 study, sponsored by Columbia University.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target

NCT00869050: Completed Phase 2 study, sponsored by Columbia University.

NCT00869050 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00869050, a Phase 2 study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study Summary

This phase II study is designed to assess whether treatment with capecitabine/temozolomide (CAP/TEM) is safe and effective in treating subjects with progressive, differentiated, metastatic neuroendocrine tumors (NET). The primary objective of the study is to determine the radiologic response rate to this regimen in progressive, metastatic, differentiated neuroendocrine cancers.

Primary Outcome

PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting \> 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.

Interventions

  • DRUG Capecitabine
  • DRUG Temozolomide

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2005-08
Est. Completion 2014-10
Phase Phase 2
Columbia University

958 total trials

What the finished NCT00869050 record still lists

NCT00869050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.

NCT00869050 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00869050 about?

NCT00869050 is a clinical study titled "Capecitabine and Temozolomide for Neuroendocrine Cancers". This phase II study is designed to assess whether treatment with capecitabine/temozolomide (CAP/TEM) is safe and effective in treating subjects with progressive, differentiated, metastatic neuroendocrine tumors (NET). The primary objective of the study is to determine the radiologic response rate to...

What is the current status of trial NCT00869050?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2005-08. Estimated completion is 2014-10.

What interventions are being tested in trial NCT00869050?

The interventions under investigation include: Capecitabine (DRUG), Temozolomide (DRUG).

Who is sponsoring clinical trial NCT00869050?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00869050's enrollment target sits among peer trials

41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00869050, the US trial registry maintained by the National Library of Medicine. NCT00869050 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.