Colorectal CancerPhase 2NCT00537823
Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement
A Phase 2 study testing Cetuximab, Bevacizumab and Leucovorin in people with Colorectal Cancer and Metastases, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastases
- What is being tested?
- Cetuximab, Bevacizumab and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Metastases
- Being tested
- Cetuximab, Bevacizumab, Leucovorin, Oxaliplatin, Fluorouracil
- Keywords
- Colorectal Cancer, Metastasis, Neoadjuvant Therapy
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
BevacizumabDrug
Also called Avastin
LeucovorinDrug
OxaliplatinDrug
FluorouracilDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Bevacizumab; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complication Rate
Fraction of patients with any grade of complication I-V
Measured: 30 days following surgery
Major Postoperative Complication Rate
Fraction of patients with any complication grades IV and V
Measured: 30 days following surgery
All-cause Mortality
Measured: 30 days following surgery
Secondary outcomes (6)
Postoperative Recurrence Patterns
Liver only vs distant disease
Measured: Up to 5 years
Histologic Hepatic Toxicity at Surgery
Measured: Time of surgery (approximately 11-16 weeks)
Nonalcoholic Steatohepatitis Score (0-3)
- NASH Scoring
- Steatosis **<5% = 0 **5-33%=1 **>33-66%=2 **>66%=3
- Lobular 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=3
- Hepatocellular ballooning None=0 Few balloon cells = 1 **Many cells/prominent ballooning=2
Measured: Time of surgery (approximately 11-16 weeks)
Liver Injury Scale Score (0-27)
Measured: 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.
Measured: 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.
Measured: Completion of neoadjuvant therapy (approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionJul 2011
Why it stopped: Poor accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Linehan, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537823
- Sponsor's protocol ID
- 07-0182
- Status last verified
- Oct 2016
- First submitted
- 27 Sep 2007
- Last updated
- 20 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
Adam R, Avisar E, Ariche A, Giachetti S, Azoulay D, Castaing D, Kunstlinger F, Levi F, Bismuth F. Five-year survival following hepatic resection after neoadjuvant therapy for nonresectable colorectal. Ann Surg Oncol. 2001 May;8(4):347-53. doi: 10.1007/s10434-001-0347-3.
PubMed 11352309Alberts SR, Horvath WL, Sternfeld WC, Goldberg RM, Mahoney MR, Dakhil SR, Levitt R, Rowland K, Nair S, Sargent DJ, Donohue JH. Oxaliplatin, fluorouracil, and leucovorin for patients with unresectable liver-only metastases from colorectal cancer: a North Central Cancer Treatment Group phase II study. J Clin Oncol. 2005 Dec 20;23(36):9243-9. doi: 10.1200/JCO.2005.07.740. Epub 2005 Oct 17.
PubMed 16230673Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A; Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) Investigators. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004 Jun 3;350(23):2343-51. doi: 10.1056/NEJMoa032709.
PubMed 15175436Badarinath 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.
PubMed 16361615Capussotti L, Muratore A, Ferrero A, Massucco P, Ribero D, Polastri R. Randomized clinical trial of liver resection with and without hepatic pedicle clamping. Br J Surg. 2006 Jun;93(6):685-9. doi: 10.1002/bjs.5301.
PubMed 16703653Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992 May;111(5):518-26.
PubMed 1598671Colucci 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.
Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45. doi: 10.1056/NEJMoa033025.
PubMed 15269313Dakhil 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.
PubMed 16467983Delaunoit 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.
PubMed 15677624Díaz 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.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-duration Preoperative Neoadjuvant Therapy With FOLFOX Based Therapy on Morbidity After Liver Resection for Colorectal Cancer Metastases
- ClinicalTrials.gov ID
- NCT00537823
- Acronym / sponsor ID
- 07-0182
- Conditions
- Colorectal Cancer, Metastases
- Keywords
- Colorectal Cancer, Metastasis, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Oct 2007 (estimated)
- Results
- Posted 20 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Wildtype | Experimental | Drug: Cetuximab, Drug: Leucovorin, Drug: Oxaliplatin, Drug: FluorouracilNeoadjuvant 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 |
| Arm 2 K-Ras 12/13 codon mutation | Experimental | Drug: Bevacizumab, Drug: Leucovorin, Drug: Oxaliplatin, Drug: FluorouracilNeoadjuvant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Synchronous or metachronous colorectal metastases
- Technically resectable liver metastases
- Medically suitable candidate for major liver resection
- FDG-PET scan without metastatic disease outside the liver
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: Erbitux | Drug | Arm 1 - Wildtype |
| BevacizumabAlso: Avastin | Drug | 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 |
Primary outcome
Postoperative Complication Rate
Time frame: 30 days following surgery
Fraction of patients with any grade of complication I-V
Major Postoperative Complication Rate
Time frame: 30 days following surgery
Fraction of patients with any complication grades IV and V
All-cause Mortality
Time frame: 30 days following surgery
6 secondary outcomes
Postoperative Recurrence Patterns
Time frame: Up to 5 years
Histologic Hepatic Toxicity at Surgery
Time frame: Time of surgery (approximately 11-16 weeks)
Nonalcoholic Steatohepatitis Score (0-3)
Time frame: Time of surgery (approximately 11-16 weeks)
Liver Injury Scale Score (0-27)
Time frame: Time of surgery (approximately 11-16 weeks)
Effect of Preoperative Chemotherapy on Tumor Size
Time frame: Upon completion of neoadjuvant chemotherapy (approximately 2 months)
Change in Tumor Size From Pretreatment to Preoperative CT Scan
Time frame: Completion of neoadjuvant therapy (approximately 8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAdam 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.
- Background: PubMed 11352309Adam R, Avisar E, Ariche A, Giachetti S, Azoulay D, Castaing D, Kunstlinger F, Levi F, Bismuth F. Five-year survival following hepatic resection after neoadjuvant therapy for nonresectable colorectal. Ann Surg Oncol. 2001 May;8(4):347-53. doi: 10.1007/s10434-001-0347-3.
- Background: PubMed 16230673Alberts SR, Horvath WL, Sternfeld WC, Goldberg RM, Mahoney MR, Dakhil SR, Levitt R, Rowland K, Nair S, Sargent DJ, Donohue JH. Oxaliplatin, fluorouracil, and leucovorin for patients with unresectable liver-only metastases from colorectal cancer: a North Central Cancer Treatment Group phase II study. J Clin Oncol. 2005 Dec 20;23(36):9243-9. doi: 10.1200/JCO.2005.07.740. Epub 2005 Oct 17.
- Background: PubMed 15175436Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A; Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) Investigators. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004 Jun 3;350(23):2343-51. doi: 10.1056/NEJMoa032709.
- BackgroundBadarinath 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.
- Background: PubMed 16361615Bilchik 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.
- Background: PubMed 16703653Capussotti L, Muratore A, Ferrero A, Massucco P, Ribero D, Polastri R. Randomized clinical trial of liver resection with and without hepatic pedicle clamping. Br J Surg. 2006 Jun;93(6):685-9. doi: 10.1002/bjs.5301.
- Background: PubMed 1598671Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992 May;111(5):518-26.
- BackgroundColucci 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.
- Background: PubMed 15269313Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45. doi: 10.1056/NEJMoa033025.
- BackgroundDakhil 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
- Background: PubMed 16467983D'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.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Brain Cancer, Breast Cancer
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Linehan, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, Bevacizumab and Leucovorin in people with Colorectal Cancer and Metastases, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complication Rate (time frame: 30 days following surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00537823, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.