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

Completed · Phase 1

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT00508326

Run by

M.D. Anderson Cancer Center

People needed

27

Starts

2005-10-01

Expected to finish

2010-10-01

Last updated by the study team

2012-07-30

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically confirmed diagnosis of advanced malignancy and liver involvement as dominant site of metastasis.
• Performance status ECOG < or = 2 (Requires occasional assistance but is able to care for own needs).
• Adequate renal function (serum creatinine < 2.0 mg/dL).
• Adequate hepatic function (Total bilirubin < 2.0 mg/dL; ALT </= 5 times upper normal reference value).
• Bone marrow function (ANC >or =1.5 cells/mcL; PLT > or = 100,000 cells/mcL).
• At least three weeks from previous therapy and complete recovery from all associated acute toxicities.
• Ability to fully read, comprehend, and sign informed consent forms.
• 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.
• 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.
• Patients of both genders, 13 year-old or older.

You may not qualify if…

• Clinical or radiographic evidence of ascites.
• Pregnant or breastfeeding females.
• Hypersensitivity to paclitaxel compounds.
• History of severe hypersensitivity reactions to products containing polyoxyethylated castor oil or Cremophor.
• Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
• Untreatable bleeding diathesis.
• Portal vein thrombosis.
• Peripheral neuropathy > Grade 1 according to NCI CTC v.3.0: sensory alteration not interfering with function).
• Untreated (radiation therapy, chemotherapy, surgery or a combination of modalities) brain metastasis.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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