Cisplatin HAI Study in 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 safe dose of cisplatin that can be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver. PRIMARY Objectives: To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial hepatic (HAI) cisplatin with systemic intravenous liposomal doxorubicin in patients with cancer metastatic to the liver. SECONDARY Objectives: To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin.

Key facts

Study ID

NCT00507962

Run by

M.D. Anderson Cancer Center

People needed

51

Starts

2005-03-01

Expected to finish

2011-05-01

Last updated by the study team

2012-08-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Histologically confirmed diagnosis of malignancy and liver involvement as dominant site of metastasis (over 50% of all tumor burden).
• Pediatric patients eligible at the discretion of the primary investigator.
• Performance Status Equivalent or Grater than 60% in the Karnofsky's Performance scale (Requires occasional assistance but is able to care for own needs).
• Adequate Renal Function (Serum CRE </= 1.5 mg/dL) or calculated Creatinine Clearance >/= 50 ml/min (Cockcroft Formula).
• Adequate Hepatic Function (Total Bilirubin </= 1.5 mg/dL or ALT </= 5 times upper normal reference value).
• Adequate Bone Marrow Function (Absolute neutrophil count (ANC) >/= 1.5 cells/uL; number of platelets (PLT) >/= 100,000 cells/uL).
• At least three weeks from previous cytotoxic chemotherapy before day 1 of HAI infusion. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter.
• All Females in Childbearing Age MUST have a negative urine or serum Human chorionic gonadotropin or human chorionic gonadotrophin (hCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity).
• Ability to fully read, comprehend, and sign informed consent forms. In pediatric patients, the informed consent forms will be signed by a parent or legal guardian.
• Patients with germ cell tumors and lymphoma MUST have had documented progression of disease prior to enrollment.

You may not qualify if…

• Clinical or radiographic evidence of Ascites.
• Pregnant females.
• Hypersensitivity to platinum compounds or anthracyclines.
• Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
• Jaundice. (Bilirubin > 1.5 mg/dL).
• Bleeding Diathesis.(Prothrombin time > 20 secs or International Normalized Ratio (INR) > 2.0).
• Portal vein thrombosis.
• Grade 2 Peripheral Neuropathy (CTC V3.0: Sensory alteration interfering with function but not interfering with ADL)
• Medical History or Clinical Evidence of Congestive Heart Failure.

Where it is running

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

Full record on ClinicalTrials.gov

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