At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 344 enrolled

Drug / intervention

Cetuximab +1 morebiological

Likely dose

Cetuximab dose not specified; FOLFOX-4: Oxaliplatin 200 mg/m² IV over 120 minutes on days 1–2 every 2 weeks, Folinic acid 200 mg/m² IV over 120 minutes on days 1–2 every 2 weeks, 5-FU bolus 400 mg/m²/day IV over 2–4 minutes followed by 600 mg/m²/day continuous infusion over 22 hours on days 1–2 every 2 weeksAI-extracted

Key inclusion· 3

✓First-line metastatic colorectal cancer (no prior systemic therapy for mCRC except adjuvant >6 months prior)
✓EGFR-positive disease
✓Bi-dimensional measurable disease

Key exclusion· 7

✕Prior exposure to EGFR-targeting therapy (e.g., cetuximab, panitumumab)
✕Prior oxaliplatin-based chemotherapy
✕Prior chemotherapy for colorectal cancer, except adjuvant treatment with progression >6 months after adjuvant completion
✕Brain metastases or leptomeningeal disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00125034

NCT00125034Phase 2Completed

Compare CT.gov

Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer

Merck KGaA, Darmstadt, Germany·interventional·Posted Jul 29, 2005·Updated Aug 7, 2014

In Brief

A Phase 2 clinical trial evaluating Cetuximab and Oxaliplatin for Neoplasm Metastasis and Colorectal Cancer. Completed, enrolled 344 participants across 78 sites in 13 countries.

Detailed Summary

This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsNeoplasm Metastasis, Colorectal Cancer

CountriesAustria, Belgium, France, Germany, Greece, Israel, Italy, Poland, Portugal, Romania, Russia, Spain, Ukraine

Collaborators--

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2005

First PostedJul 2005

Primary CompletionMar 2007

Study CompletionNov 2010

TodayJul 2026

First PostedJul 29, 2005

Enrollment StartJul 1, 2005

Primary CompletionMar 1, 2007

Study CompletionNov 1, 2010

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 20.9 years ago

Interventions

Cetuximabbiological

Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops

Oxaliplatindrug

Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops