Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 12
• Participant gender: Both

Summary

The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Doxorubicin; Ethiodized Oil; Liposomal doxorubicin; Mitomycin; Mitomycins
• Last Updated: 2016-09-23

Criteria

Inclusion Criteria:

• Participants 18 years and older;

• Biopsy-proven neuroendocrine tumor with tumor burden dominant in the liver.

• Measurable metastasis to liver with at least one dimension ≥ 1.0 cm. Known extrahepatic disease should be limited to lymph nodes of less than 2 cm and/or bone metastases.

• Liver tumor burden less than or equal to 70%.

• Not a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.

• Symptoms uncontrolled by somatostatin analogues OR morphologically progressive tumor by RECIST 1.1 criteria in the liver OR baseline tumor burden >25% of the liver volume.

• There must be no plans for the patient to receive other concomitant therapy while on this protocol treatment (other than Sandostatin or BIS-Phosphanate therapy).

• Presence of hepatopetal flow

• Performance status 0-2 on Zubrod Performance Scale (see Appendix V);

• Serum creatinine < 2.0 mg/dl;

• Serum Bilirubin ≤ 2.0

• Serum albumin ≥ 3.0

• Platelet count > 50,000/ul (corrected if needed)

• INR ≤ 1.5 (corrected if needed)

• All patients must be informed of the investigational nature of this study and must sign a study specific informed consent in accordance with institutional and federal guidelines prior to study entry.

Exclusion Criteria:

• Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

• Prior hepatic arterial therapy or hepatic radiation therapy. Prior surgical resection or ablation of liver metastases is acceptable. Patients must be at least one month beyond prior radiotherapy or surgery, and 6 months beyond chemotherapy and have recovered from all therapy-associated toxicities.

• Extensive extrahepatic tumor (not just confined to lymph nodes/bone metastases)

• Active infection (Symptomatic bacterial and fungal infection - newly diagnosed and/or requiring treatment);

• Choledochoenteric anastomosis; transpapillary biliary stent, or sphincterotomy of duodenal papilla

• Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).

• Contraindications to arteriography and selective visceral catheterization:

1. severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine.

2. bleeding diathesis not correctable by usual forms of therapy.

3. severe peripheral vascular disease precluding catheterization.

• Contraindications to hepatic artery embolization:

1. high risk of hepatic failure, indicated by the constellation of greater than 50% liver replacement by tumor, LDH>425 mU/ml, SGOT(AST)>100mU/ml. and bilirubin >2 mg./dl.

2. portal vein occlusion without hepatopedal collateral flow demonstrated by angiography; or portal hypertension with hepatofugal flow.

3. hepatic encephalopathy.