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| Name | Class |
|---|---|
| Virginia Mason Hospital/Medical Center | OTHER |
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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?
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pump Therapy | Experimental | All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic pump and Codman catheter | Device | All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients requiring stent replacements | 1 year | |
| Percent frequency liver toxicity | Alkaline phosphatase percent toxicity, Serum bilirubin percent toxicity | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinically 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 VMMC
Participant may have completely resected hepatic metastases without current evidence of other metastatic disease
Lab values ≤14 days prior to registration:
ANC ≥ 1.0(9)/L Platelet count ≥ 75 (9)/L Creatinine ≤1.8 mg/dL AST 0 to 2x reference value ALK PHOS 0 to < 1.2 x reference value Tot Bili 0 to < 1.2 x reference value
Prior chemotherapy is acceptable if last dose of oxaliplatin or irinotecan is given ≥3 weeks prior to planned first dosing on this protocol. 5-FU or 5-FU leucovorin may be given ≥2 weeks prior to planned first dosing on this protocol. [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
ECOG <=1
Participants ≥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)
Colorectal cancer that is BRAF mutant or defective in mismatch repair.
Active infection, ascites, hepatic encephalopathy
Female participants who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female participants of child-bearing potential must have negative pregnancy test ≤72 hours before treatment start)
If in the opinion of the treating investigator a participant has any serious medical problems which may preclude receiving this type of treatment
Participants with current evidence of hepatitis A, B, C (i.e., active hepatitis)
Participants 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hagen Kennecke, MD | Contact | 206-223-6193 | Hagen.Kennecke@virginiamason.org |
| Name | Affiliation | Role |
|---|---|---|
| Hagen Kennecke, MD | Virginia mason medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia mason medical Center | Recruiting | Seattle | Washington | 98101 | United States |
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Pilot non- randomized safety study
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| Floxuridine (FUDR) | Drug | Please see Detailed Description. |
|
| Gemcitabine | Drug | Please see Detailed Description. |
|
| Oxaliplatin | Drug | Please see Detailed Description. |
|
| Irinotecan (CPT-11) | Drug | Please see Detailed Description. |
|
| Fluorouracil | Drug | Please see Detailed Description. |
|
| Anti-EGFR (Panitumumab or Cetuximab) | Drug | Please see Detailed Description. |
|
| 1 year |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D005467 | Floxuridine |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| D000077544 | Panitumumab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D003857 | Deoxyuridine |
| D014529 | Uridine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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