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COMPLETED Phase 2

Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer

NCT00444678 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 36 participants
Start Date 2004-06-01
Est. Completion 2015-06-01
Phase Phase 2

Sponsor

NYU Langone Health

1,204 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00444678

The ClinicalTrials.gov registry entry for NCT00444678 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00444678 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00444678?

The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), Cetuximab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00444678?

This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial