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

Effect of Short-duration Preoperative Neoadjuvant Therapy With FOLFOX Based Therapy on Morbidity After Liver Resection for Colorectal Cancer Metastases

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Metastases
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Cetuximab; Drug: Leucovorin; Drug: Fluorouracil; Drug: Bevacizumab

Detailed Description

Although early stage, localized colon and rectal cancers are associated with 5 year survival rates of nearly 90%, only a minority of patients present with localized disease. Unfortunately, at the time of their initial presentation, approximately 35% of patients with colon or rectal cancer have metastatic disease. Nearly two thirds of these patients with stage IV disease have evidence of extrahepatic spread and have a median overall survival rate of 8-10 months in the absence of further treatment. Even with the most intensive chemotherapeutic regimens, the median overall survival for these patients ranges from 12 months to 20 months. However, a small subset of patients with stage IV disease has isolated hepatic metastatic disease and can undergo resection. The patients with completely resected liver metastases enjoy a significantly higher overall five-year survival, which is as high as 58% in carefully selected patients. Ten-year overall survival has been reported in 22% of patients. Despite this improvement, the five-year disease-free survival for these patients is at best 35%, with hepatic recurrences occurring in 46%.

The fact that adjuvant chemotherapy improves the three-year survival rate for stage II disease and five-year survival rates for stage III disease implies that it can treat micrometastatic disease in some fraction of patients. Because micrometastatic disease is likely the cause of the high recurrence rate in patients who undergo liver resection, there is a clear biologic rationale for using postoperative adjuvant chemotherapy after liver resection. Although this strategy is a common practice in many centers, no convincing data that this improves survival have been reported. A large randomized phase III trial (EORTC 40983) examining this question is currently ongoing and effect on survival has not yet been reported. Given that systemic chemotherapy after liver resection remains of unproven benefit at the present time, many have wondered if preoperative treatment might have more promise in improving recurrence rates.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - Wildtype; 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: Oxaliplatin; Drug: Cetuximab; Other Names: Erbitux; Drug: Leucovorin; Drug: Fluorouracil
Experimental: Arm 2 K-Ras 12/13 codon mutation; 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: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil; Drug: Bevacizumab; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Recurrence Patterns	Liver only vs distant disease	Up to 5 years
Histologic Hepatic Toxicity at Surgery		Time of surgery (approximately 11-16 weeks)
Nonalcoholic Steatohepatitis Score (0-3)	NASH ScoringSteatosis **<5% = 0**5-33%=1**>33-66%=2**>66%=3Lobular inflammation**No foci=0**<2 foci per x 200 field=1**2-4 foci per x 200 field=2**>4 foci per x 200 field=3Hepatocellular ballooning **None=0 **Few balloon cells = 1 **Many cells/prominent ballooning=2	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	Number of participants whose tumor size decreased from baseline to completion of preoperative chemotherapy.	Upon completion of neoadjuvant chemotherapy (approximately 2 months)
Change in Tumor Size From Pretreatment to Preoperative CT Scan	-Compare total longest diameter from baseline to preoperative CT scan.	Completion of neoadjuvant therapy (approximately 8 weeks)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: David Linehan, M.D., Washington University School of Medicine

Publications and helpful links

General Publications

• Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.
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• Vauthey JN, Pawlik TM, Ribero D, Wu TT, Zorzi D, Hoff PM, Xiong HQ, Eng C, Lauwers GY, Mino-Kenudson M, Risio M, Muratore A, Capussotti L, Curley SA, Abdalla EK. Chemotherapy regimen predicts steatohepatitis and an increase in 90-day mortality after surgery for hepatic colorectal metastases. J Clin Oncol. 2006 May 1;24(13):2065-72. doi: 10.1200/JCO.2005.05.3074.
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• Adam R, Aloia T, Figueras J, Capussotti L, Poston G, Mentha G, Selzner M, and the LiverMetSurvey Scientific Committee. LiverMetSurvey: Analysis of clinicopathologic factors associated with the efficacy of preoperative chemotherapy in 2,122 patients with colorectal liver metastases. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 3521.
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• Badarinath S, Mitchell EP, Jennis A, Graham CD, Hansen VL, Henderson CA, Chen TT, Langer C. Cetuximab plus FOLFOX for colorectal cancer (EXPLORE): Preliminary safety analysis of a randomized phase III trial. Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 3531.
• Bilchik AJ, Poston G, Curley SA, Strasberg S, Saltz L, Adam R, Nordlinger B, Rougier P, Rosen LS. Neoadjuvant chemotherapy for metastatic colon cancer: a cautionary note. J Clin Oncol. 2005 Dec 20;23(36):9073-8. doi: 10.1200/JCO.2005.03.2334. No abstract available. Erratum In: J Clin Oncol. 2006 Apr 1;24(10):1648.
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• Colucci G, Giuliani F, Mattioli R, Garufi C, Mallamaci R, Pezzella G, Lopez M, Maiello E. FOLFOX-4 + cetuximab in untreated patients with advanced colorectal cancer. A phase II study of the Gruppo Oncologico dell'Italia Meridionale . Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 3559.
• Dakhil S, Cosgriff T, Headley D, Badarinath S, International Oncology Network, R. V. Boccia. Cetuximab + FOLFOX6 as first line therapy for metastatic colorectal cancer. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S, 2006: 3557
• D'Angelica M, Maddineni S, Fong Y, Martin RC, Cohen MS, Ben-Porat L, Gonen M, DeMatteo RP, Blumgart LH, Jarnagin WR. Optimal abdominal incision for partial hepatectomy: increased late complications with Mercedes-type incisions compared to extended right subcostal incisions. World J Surg. 2006 Mar;30(3):410-8. doi: 10.1007/s00268-005-0183-x.
• Delaunoit T, Alberts SR, Sargent DJ, Green E, Goldberg RM, Krook J, Fuchs C, Ramanathan RK, Williamson SK, Morton RF, Findlay BP. Chemotherapy permits resection of metastatic colorectal cancer: experience from Intergroup N9741. Ann Oncol. 2005 Mar;16(3):425-9. doi: 10.1093/annonc/mdi092. Epub 2005 Jan 27.
• Díaz Rubio E, JTabernero J, van Cutsem E, Cervantes A, André T, Humblet Y, Soulié P, Corretgé S, Kisker O,de Gramont A. Cetuximab in combination with oxaliplatin/5-fluorouracil (5-FU)/folinic acid (FA) (FOLFOX-4) in the first-line treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer: An international phase II study. Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings. Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005: 3535.
• Ellis LM, Curley SA, Grothey A. Surgical resection after downsizing of colorectal liver metastasis in the era of bevacizumab. J Clin Oncol. 2005 Aug 1;23(22):4853-5. doi: 10.1200/JCO.2005.23.754. No abstract available.
• Fausto N, Campbell JS, Riehle KJ. Liver regeneration. Hepatology. 2006 Feb;43(2 Suppl 1):S45-53. doi: 10.1002/hep.20969.
• Fernandez FG, Drebin JA, Linehan DC, Dehdashti F, Siegel BA, Strasberg SM. Five-year survival after resection of hepatic metastases from colorectal cancer in patients screened by positron emission tomography with F-18 fluorodeoxyglucose (FDG-PET). Ann Surg. 2004 Sep;240(3):438-47; discussion 447-50. doi: 10.1097/01.sla.0000138076.72547.b1.
• Finkelstein SE, Fernandez FG, Dehdashti F, Siegel BA, Hawkins WG, Linehan DC, Strasberg SM. Unique site- and time-specific patterns of recurrence following resection of colorectal carcinoma hepatic metastases in patients staged by FDG-PET. J Hepatobiliary Pancreat Surg. 2008;15(5):483-7. doi: 10.1007/s00534-007-1237-2. Epub 2008 Oct 4.
• Gruenberger T, Sorbye H, Debois M, Bethe U, Primrose J, Rougier P, Jaeck D, Finch-Jones M, Van Cutsem E, Nordlinger B. Tumor response to pre-operative chemotherapy (CT) with FOLFOX-4 for resectable colorectal cancer liver metastases (LM). Interim results of EORTC Intergroup randomized phase III study 40983. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 3500.
• Ibrahim S, Chen CL, Wang CC, Wang SH, Lin CC, Liu YW, Yang CH, Yong CC, Concejero A, Cheng YF. Liver regeneration and splenic enlargement in donors after living-donor liver transplantation. World J Surg. 2005 Dec;29(12):1658-66. doi: 10.1007/s00268-005-0101-2.
• Jennis A , J. Polikoff, E. Mitchell, S. Badarinath, C. Graham, T. Chen, T. Gustafson, C. Langer Erbitux (Cetuximab) Plus FOLFOX for Colorectal Cancer (EXPLORE): Preliminary efficacy analysis of a randomized phase III trial. Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings. Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005: 3574
• Karoui M, Penna C, Amin-Hashem M, Mitry E, Benoist S, Franc B, Rougier P, Nordlinger B. Influence of preoperative chemotherapy on the risk of major hepatectomy for colorectal liver metastases. Ann Surg. 2006 Jan;243(1):1-7. doi: 10.1097/01.sla.0000193603.26265.c3.
• Koniaris LG, McKillop IH, Schwartz SI, Zimmers TA. Liver regeneration. J Am Coll Surg. 2003 Oct;197(4):634-59. doi: 10.1016/S1072-7515(03)00374-0. No abstract available.
• Lorenz M, Staib-Sebler E, Gog C, Proschek D, Jauch KW, Ridwelski K, Hohenberger W, Gassel HJ, Lehmann U, Vestweber KH, Padberg W, Zamzow K, Muller HH. Prospective pilot study of neoadjuvant chemotherapy with 5-fluorouracil, folinic acid and oxaliplatin in resectable liver metastases of colorectal cancer. Analysis of 42 neoadjuvant chemotherapies. Zentralbl Chir. 2003 Feb;128(2):87-94. doi: 10.1055/s-2003-37760.
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• Reddy GK. The addition of bevacizumab to FOLFOX4 prolongs survival in relapsed colorectal cancer: interim data from the ECOG 3200 trial. Clin Colorectal Cancer. 2005 Jan;4(5):300-1. doi: 10.1016/s1533-0028(11)70131-1. No abstract available.
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• Tabernero JM, Van Cutsem E, Sastre J, Cervantes A, Van Laethem JL, Humblet Y, Soulié P, Corretgé S, Mueser M, De Gramont A; Vall d'Hebron. An international phase II study of cetuximab in combination with oxaliplatin/5-fluorouracil (5-FU)/folinic acid (FA) (FOLFOX-4) in the first-line treatment of patients with metastatic colorectal cancer (CRC) expressing Epidermal Growth Factor Receptor (EGFR). Preliminary results. Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 3512.
• Taieb J, Artru P, Paye F, Louvet C, Perez N, Andre T, Gayet B, Hebbar M, Goebel FM, Tournigand C, Parc R, de Gramont A. Intensive systemic chemotherapy combined with surgery for metastatic colorectal cancer: results of a phase II study. J Clin Oncol. 2005 Jan 20;23(3):502-9. doi: 10.1200/JCO.2005.05.082.
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• Venook A, Niedzwiecki D, Hollis D, Sutherland S, Goldberg R, Alberts S, Benson A, Wade J, Schilsky R, Mayer R. Phase III study of irinotecan/5FU/LV (FOLFIRI) or oxaliplatin/5FU/LV (FOLFOX) ± cetuximab for patients with untreated metastatic adenocarcinoma of the colon or rectum (MCRC): CALGB 80203 preliminary results. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 3509.
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Helpful Links

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

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 27, 2007
• First Submitted That Met QC Criteria: September 30, 2007
• First Posted (Estimate): October 1, 2007

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Neoadjuvant Therapy; Metastasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Oxaliplatin; Bevacizumab; Leucovorin; Cetuximab
• Other Study ID Numbers: 07-0182