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NCT00444678 · ClinicalTrials.gov registry record · Phase 2
Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer
A Phase 2 study of Colorectal Cancer and Neoplasm Metastasis, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT00444678: Completed Phase 2 study of Colorectal Cancer and Neoplasm Metastasis, sponsored by NYU Langone Health.
NCT00444678 is a Phase 2 study of Colorectal Cancer and Neoplasm Metastasis that has completed, run by NYU Langone Health. The registered enrollment target is 36 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00444678, a Phase 2 study of Colorectal Cancer and Neoplasm Metastasis, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase II, open label, non-randomized study in subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who have not received prior chemotherapy for metastatic disease.
Primary Outcome
The tumor response rate (RR) will be defined as the total number of subjects whose best response is partial response (PR) or complete response (CR) during the first six months of treatment, divided by the number of subjects.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG Cetuximab
Study Locations (2)
New York
- Bellevue Hospital - New York
- New York University Langone Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2004-06-01 |
| Est. Completion | 2015-06-01 |
| Phase | Phase 2 |
What the finished NCT00444678 record still lists
NCT00444678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.
NCT00444678 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00444678 about?
NCT00444678 is a clinical study titled "Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer". This is a Phase II, open label, non-randomized study in subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who have not received prior chemotherapy for metastatic disease.
What is the current status of trial NCT00444678?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2004-06-01. Estimated completion is 2015-06-01.
What conditions does trial NCT00444678 study?
This clinical trial studies the following conditions: Colorectal Cancer, Neoplasm Metastasis.
What interventions are being tested in trial NCT00444678?
The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT00444678?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00444678 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00444678's enrollment target sits among peer trials
36 312th of 381 higher than 69 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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.
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