Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma

NCT00539643 | Completed Phase 2 Results

• 1 other identifier: 07-099
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.

Conditions

Hepatocellular Carcinoma; Liver Cancer; Hepatoma

Keywords

Liver Cancer; Hepatoma; 07-099

Outcome Measures

Primary Outcomes (1)

• Response to Treatment by RECIST Criteria

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2 to 3 weeks

Secondary Outcomes (3)

• Number of Participants Evaluated for Toxicity

  1 year

• Progression Free Survival

  1 year

• Overall Survival

  1 year

Study Arms (2)

Bead Arm

ACTIVE COMPARATOR

Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.

Device: Bead Block microspheres

Bead + Dox Arm

ACTIVE COMPARATOR

Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.

Other: Bead + Dox Arm

Interventions

Bead Block microspheres DEVICE

Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis

Bead Arm

Bead + Dox Arm OTHER

Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.

Bead + Dox Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a confirmed diagnosis of HCC according to EASL criteria for diagnosis; who is not a surgical resection candidate, or refuses surgery
• Patient must be 18 years of age or older
• Patient must be Okuda stage I or II
• Patient must have an ECOG performance status of 0 or 1
• No prior chemotherapy or biotherapy within 4 weeks of scheduled embolization, with all toxicities, if any, resolved to grade \< than or = to 1
• Patient must have the following laboratory values confirmed within 14 days of registration:
• Creatinine ≤ than or = to 2.0 the institution ULN
• Platelets ≥ than or = to 50,000/mm3
• INR ≤ than or = to 2.0 for patients who are not on Coumadin
• aPTT \< or = to twice control
• Bilirubin \< 3 mg/dl
• WBC \> 3000 cells/mm3
• ANC \> 1500 cells/mm3
• Negative serum pregnancy test (Female of childbearing potential only)

You may not qualify if:

• Patient has another primary tumor, with the exception of conventional basal cell CA, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease
• Women who are pregnant or lactating
• Patient previously treated with doxorubicin
• Contraindication to angiography/embolization including: patients who cannot receive contrast 1.Severe allergic reaction to contrast despite pre-medication, 2. poor renal function; 3.Lack of arterial access (eg femoral artery occlusion); 4. other, based on judgment of the investigator
• Patient has already undergone hepatic arterial embolization for the hepatocellular cancer for which they are currently being evaluated
• Patient has received prior radiotherapy for the hepatocellular cancer for which they are currently being evaluated
• Patient has had previous local-regional treatment of the current target tumor volume
• Patient who cannot have CT scan
• Patient at very high risk for post-embolization hepatic failure: 1. Child's C cirrhosis, 2. \> 75% liver replaced by tumor
• Patients with tumors exhibiting characteristics considered contra-indications to particle embolization, including: 1. collateral vessel pathways potentially endangering normal territories during embolization, 2. arteries supplying tumor not large enough to accept LC Bead or Bead Block, 3. Presence of arterial to systemic venous shunts, 4. Presence of arterial to pulmonary vascular shunts

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Columbia University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Brown KT, Do RK, Gonen M, Covey AM, Getrajdman GI, Sofocleous CT, Jarnagin WR, D'Angelica MI, Allen PJ, Erinjeri JP, Brody LA, O'Neill GP, Johnson KN, Garcia AR, Beattie C, Zhao B, Solomon SB, Schwartz LH, DeMatteo R, Abou-Alfa GK. Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone. J Clin Oncol. 2016 Jun 10;34(17):2046-53. doi: 10.1200/JCO.2015.64.0821. Epub 2016 Feb 1.

  PMID: 26834067 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Dr. Anne Covey, MD
• Organization: Memorial Sloan Kettering Cancer Center

coveya@MSKCC.ORG

212-639-6746

Study Officials

• Karen T Brown, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 4, 2007
• Study Start: November 1, 2007
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: August 18, 2023
• Results First Posted: August 18, 2023

Record last verified: 2022-06

Locations

US (1)