Study Summary

The purpose of this study is to compare the usual treatment alone to using hepatic artery infusion chemotherapy plus the usual treatment. The addition of hepatic artery infusion chemotherapy to the usual treatment could shrink your cancer or stabilize it. But it could also cause side effects, which are described in the risks section. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if hepatic artery infusion chemotherapy increases the life of patients by 12 months or more compared to the usual approach. Hepatic artery infusion chemotherapy with floxuridine (FUDR) is already approved by the FDA for use in metastatic colorectal cancer to the liver. But this therapy is only available at a small number of hospitals and most of the time it is not used until standard chemotherapy stops working. There will be about 408 people taking part in this study.

This study has 2 study groups. We will use a computer to assign you to one of the study groups. This process is called “randomization.” It means that your doctor will not choose and you cannot choose which study group you are in. You will be put into a group by chance. You are twice more likely to be randomized to Group 1 than Group 2. You will be told which group you are in. You will not be allowed to switch groups.

• Group 1: If you are in this group, you will receive HAI pump chemotherapy of floxuridine via the FDA approved Intera 3000 implantable device plus the usual standard of care chemotherapy. The usual standard of care chemotherapy will be chosen by your oncologist and may consist of: FOLFOX, FOLFIRI, or OX/IRI (FOLFOXIRI will not be used in Group 1 due to unproven safety when combined with HAI chemotherapy. Your oncologist may also add a targeted infusion like cetuximab or panitumumab depending on certain factors.
• Group 2: If you are in this group, you will receive one of several standard of care chemotherapy regimens every two weeks chosen by your oncologist: FOLFOX, FOLFIRI, FOLFOXIRI, or OX/IRI. Your oncologist may also add a targeted infusion like bevacizumab, cetuximab or panitumumab depending on certain factors. Your doctor may prescribe an oral medication called Capecitabine instead of 5-FU as a substitute.

After you finish standard of care chemotherapy with or without hepatic artery infusion, your doctor will continue to follow your condition for 5 years and watch you for side effects, treatment response, cancer progression, and survival. Follow up will occur every 3 months and will include blood work, imaging, and clinic visits.

Protocol: 24-2002 / IRB24-2002
Phase: III
Investigator: Vanessa Wookey, MD
Disease(s): Colon, Rectum

Location(s): Fox Chase Cancer Center at Cottman Ave.

Full Title: A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial

ClinicalTrials.gov
Visit ClinicalTrials.gov for a full clinical trial description.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC). Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes). NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study. Patient may have calcified pulmonary nodules, and/or =< 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each measuring =< 6 mm in maximal axial dimension. Patient's primary tumor may be in place.
• Patient must have received 3-6 months of previous first-line chemotherapy that meet one of the following three criteria: a) have received at least 6 but no more than 12 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14 days) OR b) have received at least 4 but no more than 8 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 21 days) OR c) have developed new colorectal liver metastases (CRLM) within 12 months of completing adjuvant systemic therapy for stage II-III colorectal cancer.
• Patient must not have had prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 2 weeks prior to randomization).
• Patient must not have cirrhosis and/or clinical or radiographic evidence of portal hypertension.

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515.