Colorectal Cancer, Cholangiocarcinoma
Conditions
Keywords
Medtronic Pump, Codman Catheter, Hepatic Arterial Infusion (HAI), Floxuridine (FUDR), Gemcitabine, Oxaliplatin, Irinotecan (CPT-11), Fluorouracil, Leucovorin Calcium (Folinic Acid), Dexamethasone, 18-343
Brief 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?
Detailed 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.
Interventions
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Please see Detailed Description.
DRUGGemcitabine
Please see Detailed Description.
DRUGOxaliplatin
Please see Detailed Description.
Please see Detailed Description.
DRUGFluorouracil
Please see Detailed Description.
Please see Detailed Description.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot non- randomized safety study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring Stent Replacements | 1 year | — |
| Number of Participants With Any Grade Liver Toxicity | 1 year | Alkaline phosphatase, serum bilirubin of any patient that received 2 cycles of pump therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival at 1 Year Assessed as the Number of Participants Who Were Alive or Dead at 1 Year | 1 year | Overall survival is defined as the time from treatment initiation till the day of death or last follow-up whichever occurs first. |
| Progression Free Survival | up to 3 years | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy Kemeny, MD
Memorial Sloan Kettering Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 13 / 15 | 7 / 16 | 3 / 4 |
| other Total, other adverse events | 0 / 15 | 0 / 16 | 0 / 4 |
| serious Total, serious adverse events | 13 / 15 | 7 / 16 | 3 / 4 |
Outcome results
None listed