Phase 1 Trial With SIR-Spheres and Cetuximab +/- Erlotinib

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of selective internal radiation (SIR)-Spheres with yttrium-90 attached and cetuximab. Some participants will also take erlotinib with this combination.

Yttrium-90 microspheres are designed to treat cancer that has spread to the liver. SIR-Spheres are designed to deliver the radiation directly to the liver. This radiation may cause the tumor cells to die.

Cetuximab and erlotinib are drugs that are designed to block the epidermal growth factor receptor (EGFR). EGFR is a protein that helps cancer cells grow. Blocking the EGFR may stop tumors from growing.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Cetuximab; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

1. Patients with advanced or metastatic cancer in the liver, with measureable or evaluable disease, that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months

2. Patients must be >/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment providing radiation is not delivered to the only site of disease being treated under this protocol

3. ECOG performance status

4. Patients must have organ and marrow function defined as: • Absolute neutrophil count >/= 500/mL; • Platelets >/=50,000/mL; creatinine2.0; ALT(SGPT)

5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence).

6. Patients must be able to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Patients who have had hepatic external beam radiotherapy.

3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to SIR-Spheres, cetuximab, or erlotinib.

4. Patients with colorectal cancer with known kRAS mutation

5. Hepatic arterial anatomy that would prevent catheterization and the administration of SIR-Spheres into the liver.

6. Greater than 20% arterio-venous shunting of SIR-Spheres to the lungs estimated from a Technetium-99m-macro-aggregated albumin (99mTc-MAA) nuclear medicine break-through scan

7. Contraindication to angiography and selective visceral catheterization: History of severe allergy or intolerance to any contract media, or atropine. Bleeding diathesis, not correctable by usual forms of therapy that would include medical coagulopathy but not limited to the administration of blood products.

8. Utilization of capecitabine for the 6 weeks preceding SIR-Spheres therapy and indefinitely following SIR-Spheres therapy as per manufacturer's recommendations due to the increased risk of radiation hepatitis.

9. Evidence of ascites, biopsy proven cirrhosis, or portal hypertension suggested by the presence of characteristic imaging features on cross-sectional imaging or esophageal varicosities, demonstrated on endoscopy or barium swallow. A diagnostic study to rule out the presence of portal hypertension will not be required unless the findings on cross sectional imaging are suggestive, but not confirmatory.