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NCT00253370 · ClinicalTrials.gov registry record · Phase 2

Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
44
Enrollment target

NCT00253370: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00253370 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00253370, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
44 participants
Enrollment target

Study Summary

This phase II trial is studying how well giving sorafenib together with docetaxel and cisplatin works in treating patients with metastatic or locally advanced gastric or gastroesophageal junction cancer that cannot be removed by surgery. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel and cisplatin may kill more tumor cells.

Primary Outcome

Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.

Interventions

  • DRUG cisplatin
  • DRUG docetaxel
  • DRUG BAY 43-9006

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2005-10
Est. Completion 2010-09
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00253370 record still lists

NCT00253370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 3 interventions - of which cisplatin is the first listed.

NCT00253370 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00253370 about?

NCT00253370 is a clinical study titled "Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer". This phase II trial is studying how well giving sorafenib together with docetaxel and cisplatin works in treating patients with metastatic or locally advanced gastric or gastroesophageal junction cancer that cannot be removed by surgery. Sorafenib may stop the growth of tumor cells by blocking some ...

What is the current status of trial NCT00253370?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2005-10. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00253370?

The interventions under investigation include: cisplatin (DRUG), docetaxel (DRUG), BAY 43-9006 (DRUG).

Who is sponsoring clinical trial NCT00253370?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00253370's enrollment target sits among peer trials

44 1322nd of 2000 higher than 669 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 NCT00253370, the US trial registry maintained by the National Library of Medicine. NCT00253370 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.