Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer

Browse trials for

• Colonic Neoplasms 1,432

Keywords

• Colon Cancer

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 36 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Lead sponsor

SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.

Study arms

• Experimental
  Intervention

  Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV

  Drug: Bevacizumab · Drug: Cetuximab · Drug: 5-fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin

Interventions

• DrugBevacizumab

  5 mg/kg IV

  Also known as: Avastin

• DrugCetuximab

  400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8

  Also known as: Erbitux

• Drug5-fluorouracil

  400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)

  Also known as: 5-FU, Adrucil

• DrugLeucovorin

  350 mg IV

  Also known as: Folinic Acid

• DrugOxaliplatin

  85 mg/m2 IV

  Also known as: Eloxatin

Primary outcomes

1. Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

   Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

   Time frame: 18 months

Secondary outcomes

1. Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

   Progression Free Survival (PFS) is defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.

   Time frame: 18 months

2. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

   Measured from the date of first treatment until the date of death from any cause

   Time frame: 36 months

3. Number of Patients With Adverse Events as a Measure of Safety With FOLFOX6 Combined With Bevacizumab and Cetuximab

   The toxicity assessments were made according to the common terminology criteria for adverse events (CTCAE version 3.0) of the National Cancer Institute. Number of participants with Grade 1 to 5 adverse events are reported here.

   Time frame: 18 months

Baseline characteristics

Publications

• Spigel DR, Greco FA, Waterhouse D, Shipley D, Lane CM, Vazquez ER, Clark BL, Infante JR, Bendell JC, Burris HA 3rd, Hainsworth JD. Phase II trial of FOLFOX6, bevacizumab, and cetuximab in the first-line treatment of metastatic colorectal cancer. Clin Adv Hematol Oncol. 2010 Jul;8(7):480-5, 498. PubMed 20864916 ↗

Related links

• Related Info ↗