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NCT00353145 · ClinicalTrials.gov registry record · Phase 2

Gemox as First and Second Line Therapy in Unknown Primary Cancer

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target

NCT00353145: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00353145 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00353145, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study Summary

Primary objectives: 1. To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer (UPC). 2. To determine the tolerability (toxicity) of this regimen in this patient population. Secondary objectives: 1. To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination. 2. To determine the impact of this combination on quality of life (QOL) in this patient population.

Primary Outcome

Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor increase to qualify for PD, reference smallest sum LD since treat

Interventions

  • DRUG Oxaliplatin
  • BEHAVIORAL Questionnaire
  • DRUG Gemcitabine (Gemox)

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2004-02
Est. Completion 2010-01
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00353145 record still lists

NCT00353145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).

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

NCT00353145 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00353145 about?

NCT00353145 is a clinical study titled "Gemox as First and Second Line Therapy in Unknown Primary Cancer". Primary objectives: 1. To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer (UPC). 2. To determine the tolerability (toxicity) of this regimen in this patient population. Secondary obje...

What is the current status of trial NCT00353145?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2004-02. Estimated completion is 2010-01.

What interventions are being tested in trial NCT00353145?

The interventions under investigation include: Oxaliplatin (DRUG), Questionnaire (BEHAVIORAL), Gemcitabine (Gemox) (DRUG).

Who is sponsoring clinical trial NCT00353145?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00353145's enrollment target sits among peer trials

29 1669th of 2000 higher than 324 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 NCT00353145, the US trial registry maintained by the National Library of Medicine. NCT00353145 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.