Study Stopped
Lack of accrual
Study of Chemotherapy With or Without Hepatic Arterial Infusion for Patients With Unresectable Metastatic Colorectal Cancer to the Liver
A Randomized, Multicenter Phase II Study of Panitumumab Plus FOLFIRI With or Without Hepatic Arterial Infusion as Second-Line Treatment in Patients With Wild Type RAS Who Have Unresectable Hepatic Metastases From Colorectal Cancer
1 other identifier
interventional
N/A
1 country
5
Brief Summary
The purpose of this study is to see if patients treated with both regional chemotherapy using the HAI pump and intravenous chemotherapy are able to have their liver tumors removed surgically (resected), versus treatment with only intravenous chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2017
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedStudy Start
First participant enrolled
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2019
CompletedMay 21, 2019
May 1, 2019
2.2 years
February 28, 2017
May 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resection rate assessed using RECIST (version 1.1)
Treatment evaluation will be done using RECIST (version 1.1) The patient will be assessed with repeat CT scans as specified. If at any time after 3 cycles (or 3 months) the patient is able to undergo a complete resection of all hepatic metastases they will proceed to operative assessment.
3 months
Study Arms (2)
HAI FUDR/Dex in addition to Pmab plus FOLFIRI
EXPERIMENTALPanitumumab plus FOLFIRI on Day 1 and Day 15 of each cycle. HAI pump therapy with FUDR and Dex on Day 1 of each cycle. Patients will start protocol therapy approximately 2 weeks after surgery. All patients will receive Panitumumab (6 mg/kg IV over 60 min). The HAI FUDR group will receive FOLFIRI in the following dosing; 5-Fluouracil (5FU) (1000 mg/m2/day continuous infusion over two days), Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour), and Irinotecan (CPT) (150 mg/m2 IV over 30 min to an hour) on Day 1 and Day 15.
Pmab plus FOLFIRI alone
EXPERIMENTALThe dosing of FOLFIRI in the systemic arm will be 5-Fluouracil (5FU) (1200 mg/m2/day continuous infusion over two days), Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour), bolus 5FU 400mg/ m2 and Irinotecan (CPT) (150 mg/m2 IV over 30 min to an hour) on Day 1 and 15.
Interventions
5-Fluouracil (5FU) (1000 mg/m2/day continuous infusion over two days)
Irinotecan (CPT) (150 mg/m2 IV over 30 min to an hour) on Day 1 and Day 15.
5-Fluouracil (5FU) (1200 mg/m2/day continuous infusion over two days)
Panitumumab (6 mg/kg IV over 60 min)
Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour)
Eligibility Criteria
You may qualify if:
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Confirmation of diagnosis must be performed by the enrolling institution.
- Patients must have a primary L sided colorectal cancer, (at or distal to the splenic flexure)
- Confirmed RAS/RAF wild type tumor. Paraffin-embedded tumor tissue obtained from the primary tumor or metastasis
- Have received prior treatment for metastatic disease with oxaliplatin-based regimen and either
- Had disease progression OR
- Had stable disease OR
- Discontinued oxaliplatin due to neuropathy
- Patients must meet the following criteria for unresectability as determined by two hepatobiliary surgeons and one radiologist:
- When a margin negative resection would require resection of all three hepatic veins, both portal veins, or the retrohepatic vena cava.
- Requiring a resection that leaves less than 2 hepatic segments (not including the caudate lobe) behind with adequate arterial/portal inflow, venous outflow and biliary drainage. \*\*
- \*\*A patient is considered resectable if the procedure includes a minor wedge or thermo-ablation encompassing 10% or less of the volume of the remaining 2 segments.
- Patient"s liver metastases must comprise \<70% of the liver parenchyma. All patients must be clinically fit to undergo surgery as determined by the pre-operative evaluation
- Lab values within 14 days prior to enrollment/randomization:
- WBC ≥ 3.0 K/uL
- ANC \> 1.5 K/uL
- +9 more criteria
You may not qualify if:
- Patients \< 18 years of age
- Patients who have received more than one chemotherapy regimen for metastatic disease
- Patients who are chemotherapy naïve
- Prior radiation to the liver (Prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration)
- Active infection
- °Active infection includes patients with positive blood cultures
- Prior treatment with HAI FUDR
- Prior TACE
- Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤ 72 hours before enrollment and randomization, and must have a negative pregnancy test ≤ 72 hours prior to treatment start)
- If a patient has any serious medical problems which may preclude receiving this type of treatment
- Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded.
- Serious or non-healing active wound, ulcer, or bone fracture
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- Patients who have a diagnosis of Gilbert"s disease
- History of other malignancy, except:
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- The Cleveland Cliniccollaborator
- Oregon Health and Science Universitycollaborator
- Queens Cancer Center of Queens Hospitalcollaborator
- Washington University School of Medicinecollaborator
Study Sites (5)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memoral Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Cercek, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 3, 2017
Study Start
February 28, 2017
Primary Completion
May 16, 2019
Study Completion
May 16, 2019
Last Updated
May 21, 2019
Record last verified: 2019-05