Status:
UNKNOWN
A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
Lead Sponsor:
Benaroya Research Institute
Collaborating Sponsors:
Virginia Mason Hospital/Medical Center
Conditions:
Colorectal Cancer
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 chemother...
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 systemi...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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
- Adequately treated non-melanomatous skin cancer or lentigo malignant without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04668976
Start Date
November 25 2020
End Date
December 1 2024
Last Update
December 21 2020
Active Locations (1)
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1
Virginia mason medical Center
Seattle, Washington, United States, 98101