Know Cancer

forgot password

Phase I Study of Paclitaxel Administered by Hepatic Artery Infusion to Patients With Advanced Cancer and Dominant Liver Involvement

Phase 1
13 Years
Not Enrolling
Advanced Cancer

Thank you

Trial Information

Phase I Study of Paclitaxel Administered by Hepatic Artery Infusion to Patients With Advanced Cancer and Dominant Liver Involvement

Paclitaxel is designed to work by blocking the mechanisms of cell division in cancer cells,
causing them to die.

Before you can start on this study, you will have what are called "screening tests." These
tests will help the doctor decide if you are eligible to take part in this study. You will
have a complete medical history and physical exam, including measurement of height, weight,
and vital signs (blood pressure, temperature, breathing rate, and heart rate). You will
have a neurological evaluation evaluating your strength and nerve function. You will be
asked to report how a pinprick or a thin brush feel when applied to your skin. About 2
tablespoons of blood and some urine samples will be collected for routine tests. Women who
are able to have children must have a negative urine pregnancy test.

If you are eligible to take part in this study, you will begin taking study drugs in cycles
of 28 days. You will be hospitalized to receive your chemotherapy. The night of the
hospital admission, you will receive fluids (normal saline) in your veins to help decrease
the risk of kidney side effects from the chemotherapy. The morning after your admission to
the hospital, you will be taken to the interventional radiology suite, and a catheter (a
thin plastic tube) will be placed in your groin area and advanced to the liver. You must be
on bedrest the entire time that the catheter is in place. After the procedure, you will go
to Nuclear Medicine, and a test called "flow study" will be carried out to confirm the right
position of the catheter. After your return to the room, the nurses will start the
chemotherapy. You will receive paclitaxel nonstop over 24 hours through the catheter (a thin
plastic tube) into the artery that carries blood to your liver. You will repeat this
procedure once every month.

The catheter will be carefully taped so that it can not move and to prevent it from coming
out while you are receiving chemotherapy. You will be asked to lie flat on your back while
the treatment takes place. In some cases, the catheter will be removed immediately after
your chemotherapy infusions is complete. In some cases, the catheter will remain in longer.
You will be on bedrest until the catheter is removed. When the catheter is pulled, pressure
will be applied to the groin for 15 minutes. The catheter will be removed by someone
experienced in the procedure. The catheter will be placed and removed for each cycle of
chemotherapy. Blood (about 2 teaspoons) will be drawn for blood counts and liver function
tests, before each dose, to be sure researchers are safely giving you the paclitaxel.

You will be seen by a doctor or advanced practitioner every day while you are in the
hospital. You will be hospitalized for about 3-5 days until recovery from all immediate
chemotherapy-related side effects. The charges of your hospitalization will be billed to you
or your insurance carrier.

You will continue to receive the chemotherapy once every 28 days, unless the disease gets
worse or intolerable side effects occur. Every 2 months and at the end of your
participation in this study, you will have scans to see if your tumors are growing or
shrinking and blood work (about 3 teaspoons) will be performed for safety tests. These tests
can be performed at your doctor's office and the results faxed to the study doctor at M. D.

In addition, you will be asked to call the research nurse in charge of this study at
713-745-1042 to report on your health status every week for 30 days after the last dose of
the drug or until you start a new course of therapy.

This is an investigational study. The chemotherapy you will be given is FDA approved. The
cost of being on these medications will be billed to you or your insurance company. About
59 patients will take part in this study. All will be enrolled at M. D. Anderson.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose of Monthly Cytotoxic Intraarterial Hepatic Paclitaxel

Outcome Time Frame:


Safety Issue:


Principal Investigator

Apostolia M. Tsimberidou, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

October 2010

Related Keywords:

  • Advanced Cancer
  • Advanced Cancer
  • Solid Tumor
  • Liver Metastasis
  • Hepatic Artery Infusion
  • Liver
  • Paclitaxel
  • Taxol
  • Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030