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Colorectal Adenocarcinoma Metastatic to the LiverPhase 2NCT03069950

Study of Chemotherapy With or Without Hepatic Arterial Infusion for Patients With Unresectable Metastatic Colorectal Cancer to the Liver

A Phase 2 study testing Floxuridine (FUDR), Irinotecan (CPT-11) and FLUOROURACIL in people with Colorectal Adenocarcinoma Metastatic to the Liver, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Floxuridine (FUDR), Irinotecan (CPT-11) and FLUOROURACIL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
5 sitesUnited States
Study dates
28 Feb 2017to 16 May 2019
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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
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  • 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
  • Platelets ≥ 100,000/uL
  • Renal function (≤ 10 days prior to enrollment/randomization) °Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method as follows:
  • Cockcroft-Gault method as follows:
  • Male creatinine clearance = (140 -age in years) x (weight in Kg) / (serum Cr in mg/dl x 72)
  • Female creatinine clearance = (140 - age in years) x (weight in Kg) x 0.85 / (serum Cr in mg/dl x 72) (use of creatinine clearance per protocol based on chemotherapy regimen)
  • Hepatic function, as follows: (≤ 10 days prior to enrollment/randomization)
  • Total Bilirubin ≤ 1.5 mg/dl
  • Calcium ≥ lower limit of normal (≤ 48 hours prior to enrollment/randomization)
  • KPS ≥ 60% (ECOG (or Karnofsky) performance status (preferably 0 or 1/≥ 60% for Karnofsky))

Who cannot join

  • 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
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  • 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:
  • Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician
  • Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memoral Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: 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

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.

Being tested
Floxuridine (FUDR), Irinotecan (CPT-11), FLUOROURACIL, PANITUMUMAB, DEXAMETHASONE
Keywords
Hepatic Arterial Infusion, Floxuridine (FUDR), Irinotecan (CPT-11), FLUOROURACIL, PANITUMUMAB, 16-1341

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Floxuridine (FUDR)Drug

    5-Fluouracil (5FU) (1000 mg/m2/day continuous infusion over two days)

  • Irinotecan (CPT-11)Drug

    Irinotecan (CPT) (150 mg/m2 IV over 30 min to an hour) on Day 1 and Day 15.

  • FLUOROURACILDrug

    5-Fluouracil (5FU) (1200 mg/m2/day continuous infusion over two days)

  • PANITUMUMABDrug

    Panitumumab (6 mg/kg IV over 60 min)

  • DEXAMETHASONEDrug

    flat dose of 25 mg on Day 1

  • LeucovorinDrug

    Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour)

Study groups in NCT03069950
Study groupRoleWhat they receive
HAI FUDR/Dex in addition to Pmab plus FOLFIRIExperimentalPanitumumab 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.
Receives: Drug: Floxuridine (FUDR); Drug: Irinotecan (CPT-11); Drug: FLUOROURACIL; Drug: PANITUMUMAB; Drug: DEXAMETHASONE; Drug: Leucovorin
Pmab plus FOLFIRI aloneExperimentalThe 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.
Receives: Drug: Floxuridine (FUDR); Drug: Irinotecan (CPT-11); Drug: FLUOROURACIL; Drug: PANITUMUMAB; Drug: Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017
  2. Study start28 Feb 2017
  3. Primary completion16 May 2019
  4. Study completion16 May 2019

Why it stopped: Lack of accrual

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03069950
Sponsor's protocol ID
16-1341
Status last verified
May 2019
First submitted
28 Feb 2017
Last updated
21 May 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Floxuridine (FUDR), Irinotecan (CPT-11) and FLUOROURACIL in people with Colorectal Adenocarcinoma Metastatic to the Liver, run by Memorial Sloan Kettering Cancer Center at 5 sites 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 24 inclusion and 18 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: withdrawn, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Resection rate assessed using RECIST (version 1.1) (time frame: 3 months). 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 NCT03069950.

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 21 May 2019.

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