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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03693807
Other study ID # 18-343
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 18, 2018
Est. completion date September 2024

Study information

Verified date October 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being done to answer the following question: Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?


Description:

Group 1 unresectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin (anti- EGFR agent may be added to any of the systemic treatments) on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. CT C/A/P every 2 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules. Group 2 resectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. Treatment will continue for 6 months in the absence of toxicity or patient withdrawal. CT C/A/P every 3 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules. Group 3 unresectable cholangiocarcinoma - Patients will receive Gemcitabine (800 mg/m2 IV over 30 minutes) and Oxaliplatin (85 mg/ m2 IV over 120 minutes) or Gemcitabine (1000 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. A CT C/A/P every 2 months during treatment. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 35
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinicalyl or radiographically confirmed extrahepatic disease (or) Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of metastatic disease that has been resected is allowed, provided there is no recurrence in that area prior to protocol consent) - Confirmation of diagnosis must be performed at MSKCC - Patient may have completely resected hepatic metastases without current evidence of other metastatic disease - Lab values =14 days prior to registration: - WBC =2.5 K/uL - Platelets =100,000/uL - Creatinine <1.7mg/dL - HGB = 8.5 gm/dL - Total Bilirubin =1.5 mg/dl - Prior chemotherapy is acceptable if last dose given =3 weeks prior to registration to this study. [Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study] - Any investigation agent is acceptable if administered =3 months before planned first dose on this protocol - KPS =60% - Patients =18 years of age Exclusion Criteria: - Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if competed at least 4 weeks prior to the planned first dose of treatment on protocol) - Active infection, ascites, hepatic encephalopathy - 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 treatment start) - If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment - Patients with current evidence of hepatitis A, B, C (i.e., active hepatitis) - 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 other malignancy, except: 1. Malignancy treated with curative intent and with no known active disease present for =3 years prior to registration and felt to be at low risk for recurrence by the treating physician 2. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease 3. Adequately treated cervical carcinoma in situ without evidence of disease There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.

Study Design


Intervention

Device:
Medtronic pump and Codman catheter
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Drug:
Floxuridine (FUDR)
Please see Detailed Description.
Gemcitabine
Please see Detailed Description.
Oxaliplatin
Please see Detailed Description.
Irinotecan (CPT-11)
Please see Detailed Description.
Fluorouracil
Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab)
Please see Detailed Description.

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of patients requiring stent replacements 1 year
Primary % frequency liver toxicity alkaline phosphatase, serum bilirubin 1 year
Secondary Overall survival Overall survival is defined as the time from treatment initiation till the day of death or last follow-up whichever occurs first. 1 year
Secondary progression free survival Progression free survival is defined as the time from treatment initiation till the day of progression or death whichever occurs first. Patients that are alive without progression at the end of the study will be censored. 1 year
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