FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

NCT01226719 | Completed Phase 2 Results

• 1 other identifier: SCRI GI 134
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 15

Brief Summary

In this Phase II study the investigators plan to determine the overall response rate (ORR) of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.

Conditions

Colorectal Cancer

Keywords

liver-only metastatic KRAS wild-type colorectal cancer; Panitumumab; Oxaliplatin; Irinotecan; Leucovorin; 5-Fluorouracil

Outcome Measures

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.

  18 months

Secondary Outcomes (4)

• R0 Resection Rate

  18 months

• Progression-free Survival (PFS)

  18 months

• To Determine the Acute Toxicity Produced by This Regimen.

  18 months

• Overall Survival (OS)

  18 months

Study Arms (1)

FOLFOXIRI+panitumumab regimen

EXPERIMENTAL

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order: * Panitumumab * Oxaliplatin * Irinotecan * Leucovorin * 5-Fluorouracil

Drug: Panitumumab; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-Fluorouracil

Interventions

Panitumumab DRUG

6 mg/kg, 60-90 minute IV infusion every 2 weeks

Also known as: Combined Modality Treatment

FOLFOXIRI+panitumumab regimen

Oxaliplatin DRUG

85 mg/m2, 2-hour IV infusion every 2 weeks

Also known as: Combined Modality Treatment

FOLFOXIRI+panitumumab regimen

Irinotecan DRUG

125 mg/m2, 1-hour IV infusion every 2 weeks

Also known as: Combined Modality Treatment

FOLFOXIRI+panitumumab regimen

Leucovorin DRUG

200 mg/m2, 2-hour IV infusion every 2 weeks

Also known as: Combined Modality Treatment

FOLFOXIRI+panitumumab regimen

5-Fluorouracil DRUG

3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Also known as: Combined Modality Treatment

FOLFOXIRI+panitumumab regimen

Eligibility Criteria

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

You may qualify if:

• Patient must have a biopsy confirmed adenocarcinoma of the colon or rectum with stage IV (metastatic) liver-only disease, as defined by staging with CT scans.
• Patients must have a baseline evaluation to determine whether liver metastases are resectable (e.g. a single liver metastasis in a resectable location)or unresectable (surgical consultation is recommended). Both groups are eligible for this study.
• Tumor tissue must reveal wild-type KRAS expression (i.e. no KRAS mutation) prior to study entry (see Section 7.4.4.).
• Patients must have at least one unidimensional measurable lesion definable by CT scan. Disease must be measurable per RECIST version 1.1 criteria (see Section 9).
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix A).
• Laboratory values as follows:
• ANC greater than 1500/μL
• Hgb greater than9 g/dL
• Platelets greater than 100,000/μL
• AST/SGOT less than 5.0 x ULN
• ALT/SGPT less than or equal to 5.0 x ULN
• Alk Phos less than or equal to 5.0 x ULN
• Bilirubin less than or equal to 1.5 x ULN
• Creatinine 1.5 mg/dL or calculated creatinine clearance 50 ml/min
• Magnesium LLN

You may not qualify if:

• Prior systemic therapy for metastatic colorectal cancer (including chemotherapy, bevacizumab, cetuximab, panitumumab, and other targeted agents).
• Adjuvant chemotherapy (and/or chemoradiation) for colorectal carcinoma ending less than or equal to 12 months prior to the diagnosis of metastatic cancer. Prior radiation therapy (in the metastatic setting) may be allowed if it was completed greater than or equal to 4 weeks prior to enrollment and measurable lesions are outside the radiation portal site.
• Any detectable metastases in areas other than the liver.
• Known liver disease or other significant medical illness that would exclude the patient as a candidate for resection of liver metastases.
• Patients requiring therapeutic coumadin or heparin (for a history of pulmonary emboli or deep vein thrombosis \[DVT\]) will be excluded.
• Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury less than or equal to 4 weeks prior to beginning treatment.
• History of Gilbert's disease.
• History of hypersensitivity to active or inactive excipients of any component of treatment (5 fluorouracil, irinotecan, panitumumab, and/or oxaliplatin), or known dipyrimidine dehydrogenase (DPD) deficiency
• Serious cardiac arrhythmia requiring medication.
• Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, an infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patient with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus or acute or chronic hepatitis B infection.
• Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
• Use of any non-approved or investigational agent less than or equal to 28 days prior to administration of the first dose of study drug.
• Past or current history of neoplasm other than the entry diagnosis with the exception of treated non melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS greater than or equal to 5 years.
• Patients with National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE) Grade 2 peripheral neuropathy.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Amgen: collaborator

Study Sites (15)

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Hope Cancer Center

Terre Haute, Indiana, 47802, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Portsmouth Regional Hospital

Portsmouth, New Hampshire, 03801, United States

Location

Hematology-Oncology Associates of Northern NJ

Morristown, New Jersey, 07960, United States

Location

Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Related Publications (1)

• Bendell JC, Zakari A, Peyton JD, Boccia R, Moskowitz M, Gian V, Lipman A, Waterhouse D, LoCicero R, Earwood C, Lane CM, Meluch A. A Phase II Study of FOLFOXIRI Plus Panitumumab Followed by Evaluation for Resection in Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only. Oncologist. 2016 Mar;21(3):279-80. doi: 10.1634/theoncologist.2015-0439. Epub 2016 Feb 24.

  PMID: 26911408 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab; Combined Modality Therapy; Oxaliplatin; Irinotecan; Leucovorin; 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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John D Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• Johanna Bendell, MD

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 22, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 27, 2015
• Results First Posted: May 27, 2015

Record last verified: 2015-05

Locations

US (15)