Overview

Cisplatin HAI Study in Patients With Advanced Cancer and Dominant Liver Involvement

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Cisplatin
Doxorubicin
Liposomal doxorubicin
Criteria
Inclusion Criteria:

1. Patients with Histologically confirmed diagnosis of malignancy and liver involvement
as dominant site of metastasis (over 50% of all tumor burden).

2. Pediatric patients eligible at the discretion of the primary investigator.

3. Performance Status Equivalent or Grater than 60% in the Karnofsky's Performance scale
(Requires occasional assistance but is able to care for own needs).

4. Adequate Renal Function (Serum CRE >/= 50 ml/min (Cockcroft Formula).

5. Adequate Hepatic Function (Total Bilirubin normal reference value).

6. Adequate Bone Marrow Function (Absolute neutrophil count (ANC) >/= 1.5 cells/uL;
number of platelets (PLT) >/= 100,000 cells/uL).

7. 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.

8. 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).

9. 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.

10. Patients with germ cell tumors and lymphoma MUST have had documented progression of
disease prior to enrollment.

Exclusion Criteria:

1. Clinical or radiographic evidence of Ascites.

2. Pregnant females.

3. Hypersensitivity to platinum compounds or anthracyclines.

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

5. Jaundice. (Bilirubin > 1.5 mg/dL).

6. Bleeding Diathesis.(Prothrombin time > 20 secs or International Normalized Ratio (INR)
> 2.0).

7. Portal vein thrombosis.

8. Grade 2 Peripheral Neuropathy (CTC V3.0: Sensory alteration interfering with function
but not interfering with ADL)

9. Medical History or Clinical Evidence of Congestive Heart Failure.