Overview

Paclitaxel Administered by HAI to Patients With Advanced Cancer and Dominant Liver Involvement

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is find the highest tolerated dose of paclitaxel that can be given directly into the liver of patients with advanced cancer involving the liver. Researchers also want to collect descriptive information on any effects the drug may have on tumor tissue.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
Inclusion Criteria:

1. Patients with histologically confirmed diagnosis of advanced malignancy and liver
involvement as dominant site of metastasis.

2. Performance status ECOG < or = 2 (Requires occasional assistance but is able to care
for own needs).

3. Adequate renal function (serum creatinine < 2.0 mg/dL).

4. Adequate hepatic function (Total bilirubin < 2.0 mg/dL; ALT reference value).

5. Bone marrow function (ANC >or =1.5 cells/mcL; PLT > or = 100,000 cells/mcL).

6. At least three weeks from previous therapy and complete recovery from all associated
acute toxicities.

7. Ability to fully read, comprehend, and sign informed consent forms.

8. All females in childbearing age must have a negative urine or serum HCG test unless
prior hysterectomy or menopause. Women of childbearing potential and men must use
effective birth control.

9. Patients should be refractory to standard chemotherapy or have no conventional therapy
that produces a CR rate of at least 10% or an increase in survival of at least three
months.

10. Patients of both genders, 13 year-old or older.

Exclusion Criteria:

1. Clinical or radiographic evidence of ascites.

2. Pregnant or breastfeeding females.

3. Hypersensitivity to paclitaxel compounds.

4. History of severe hypersensitivity reactions to products containing polyoxyethylated
castor oil or Cremophor.

5. Inability to complete informed consent process and adhere to protocol treatment plan
and follow-up requirements.

6. Untreatable bleeding diathesis.

7. Portal vein thrombosis.

8. Peripheral neuropathy > Grade 1 according to NCI CTC v.3.0: sensory alteration not
interfering with function).

9. Untreated (radiation therapy, chemotherapy, surgery or a combination of modalities)
brain metastasis.