Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement

NCT00537823 | Terminated Phase 2 Results

• 1 other identifier: 07-0182
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of short-duration pre-operative FOLFOX based therapy on postoperative problems after liver surgery for patients with metastatic colorectal cancer.

Conditions

Colorectal Cancer; Metastases

Keywords

Colorectal Cancer; Metastasis; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (3)

• Postoperative Complication Rate

  Fraction of patients with any grade of complication I-V

  30 days following surgery

• Major Postoperative Complication Rate

  Fraction of patients with any complication grades IV and V

  30 days following surgery

• All-cause Mortality

  30 days following surgery

Secondary Outcomes (6)

• Postoperative Recurrence Patterns

  Up to 5 years

• Histologic Hepatic Toxicity at Surgery

  Time of surgery (approximately 11-16 weeks)

• Nonalcoholic Steatohepatitis Score (0-3)

  Time of surgery (approximately 11-16 weeks)

• Liver Injury Scale Score (0-27)

  Time of surgery (approximately 11-16 weeks)

• Effect of Preoperative Chemotherapy on Tumor Size

  Upon completion of neoadjuvant chemotherapy (approximately 2 months)

Study Arms (2)

Arm 1 - Wildtype

EXPERIMENTAL

Neoadjuvant therapy Week 1 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2/day over 46 hours Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly Weeks 3, 5, 7 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2/day over 46 hours Wait 3-8 weeks after completion of therapy Liver resection Wait 4 weeks or until clinical status allows Adjuvant Therapy Week 1, 3, 5, 7, 9, 11, 13, 15 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2/day over 46 hours Weeks 2, 4, 6, 8, 10, 12, 16 \*Cetuximab 250 mg/m\^2 IV weekly

Drug: Cetuximab; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil

Arm 2 K-Ras 12/13 codon mutation

EXPERIMENTAL

Neoadjuvant Therapy Weeks 1, 3, 5 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV * Bevacizumab 5 mg/kg IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2 Week 7 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2 Wait 3-8 weeks after completion of therapy Liver resection Wait 4 weeks or until clinical status allows Adjuvant Therapy Weeks 1, 3, 5, 9, 11, 13 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV * Bevacizumab 5 mg/kg IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2 Week 7, 15 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2

Drug: Bevacizumab; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil

Interventions

Cetuximab DRUG

Also known as: Erbitux

Arm 1 - Wildtype

Bevacizumab DRUG

Also known as: Avastin

Arm 2 K-Ras 12/13 codon mutation

Leucovorin DRUG

Arm 1 - Wildtype; Arm 2 K-Ras 12/13 codon mutation

Oxaliplatin DRUG

Arm 1 - Wildtype; Arm 2 K-Ras 12/13 codon mutation

Fluorouracil DRUG

Arm 1 - Wildtype; Arm 2 K-Ras 12/13 codon mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Synchronous or metachronous colorectal metastases
• Technically resectable liver metastases
• Four or fewer metastases
• No tumors in porta hepatis
• Resection of no more than 70% of liver needed
• Medically suitable candidate for major liver resection
• FDG-PET scan without metastatic disease outside the liver

You may not qualify if:

• Near-obstructing or obstructing colon lesions in patients in whom combined resection is planned (as delay for preoperative chemotherapy would be medially impossible)
• Treatment with FOLFOX or cetuximab within 12 months
• Treatment with irinotecan within 12 months
• Abnormal liver function (ALT or AST \> 5x ULN, bilirubin \> 3x ULN)
• Body mass index \>/= 35 kg/m² (as the risk for steatohepatitis is increased)
• Renal insufficiency (Cr \> 2.5mg/dL)
• Interstitial lung disease (because cetuximab has been rarely associated with development of interstitial lung disease)
• ECOG performance score \>/= 3
• Patients unable to give informed consent
• Pregnant patient (as cetuximab is a Class C drug)
• Peripheral neuropathy \>/= grade II (as oxaliplatin causes neuropathy to worsen)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (42)

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Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Cetuximab; Bevacizumab; Leucovorin; Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: David Linehan, M.D.
• Organization: Washington University School of Medicine

David_Linehan@URMC.Rochester.edu

Study Officials

• David Linehan, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2011
• Last Updated: December 20, 2016
• Results First Posted: December 20, 2016

Record last verified: 2016-10

Locations

US (1)