Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Withou… (NCT01312857) | Clinical Trial Compass
CompletedPhase 2
Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer
United States75 participantsStarted 2011-03-07
Plain-language summary
The purpose of this study is to see if Panitumumab plus the other treatments will increase the time of remission. Remission means that there is no sign of the cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 at MSKCC.
* Completely resected hepatic metastases without current evidence of other metastatic disease.
* Lab values ≤ 14 days prior to treatment start:
* WBC ≥ 3.0 K/uL
* ANC \> 1.5 K/uL
* Platelets ≥ 100,000/uL
* Creatinine \<1.5 mg/dL
* HGB ≥ 9 gm/dL Renal function (≤ 14 days prior to treatment start).
* Creatinine ≤1.5 mg/dL or creatinine clearance ≥ 50 mL/min calculated by the
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: (≤ 14 days prior to treatment start)
* Aspartate aminotransferase (AST) (≤ 5 x ULN)
* Alanine aminotransferase (ALT) (≤ 5 x ULN)
* Total Bilirubin ≤ 1.5 mg/dl
* Magnesium ≥ lower limit of normal (≤ 48 hours prior to treatment start.)
* Calcium ≥ lower limit of normal (≤ 48 hours prior to treatment start.)
* 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 investigational agent is acceptable i…
What they're measuring
1
Participants With Recurrence Free Survival for Colorectal Cancer Participants With Resected Liver Metastases