A Phase I Study Dose Escalation Clinical Study Of Hepatic Intraarterial Cisplatin, In Combination With Systemic Intravenous Liposomal Doxorubicin Administered Every Four Weeks to Patients With Advanced Cancer And Dominant Liver Involvement
N/A
N/A
Both
Advanced Cancer
Trial Information
A Phase I Study Dose Escalation Clinical Study Of Hepatic Intraarterial Cisplatin, In Combination With Systemic Intravenous Liposomal Doxorubicin Administered Every Four Weeks to Patients With Advanced Cancer And Dominant Liver Involvement
Cisplatin and Liposomal Doxorubicin are chemotherapy drugs designed to fight cancer growth.
If you are eligible to take part in this study, you will enter a treatment period that is
divided into cycles. Each cycle is 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 avoid 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 will be placed in your right groin. 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 first receive cisplatin
through the groin catheter followed by the liposomal doxorubicin given in one of your veins.
The treatment lasts less than three hours and is repeated once every month.
The catheter will be carefully taped so it can not move and to prevent it from coming out.
Following completion of chemotherapy infusion, the intra-arterial catheter will be pulled
and pressure applied to the groin for 15 minutes. 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. The
catheter will be removed by the physician on call. The catheter will be placed and removed
at each treatment.
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 liposomal doxorubicin.
Since most of the blood flow to your liver comes through the portal vein, your doctors will
try to cause an infarct (like a stroke) to the liver artery followed by the injection of
cisplatin to kill the tumor cells.
You will be seen by a doctor or advanced practice practitioner every day while you are in
the hospital. You will be hospitalized for about 5-7 days until recovery from all immediate
treatment related side effects.
You will continue to receive therapy as mentioned above until the disease gets worse or
intolerable side effects occur.
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) to make sure your blood counts
and the electrolytes (salts in your blood), kidney and liver function are at a safe level.
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.
Type of Study:
Interventional
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 (MTD)
Outcome Description:
Dose level at which no dose limiting toxicities are seen for a monthly cytotoxic regimen combining intraarterial hepatic cisplatin with systemic intravenous liposomal doxorubicin.
Outcome Time Frame:
With each 4 week cycle (28 days)
Safety Issue:
Yes
Principal Investigator
Apostolia Tsimberidou, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2004-0568
NCT ID:
NCT00507962
Start Date:
March 2005
Completion Date:
May 2011
Related Keywords:
- Advanced Cancer
- Advanced Cancer
- Dominant Liver Involvement
- Hepatic Intraarterial Cisplatin
- Cisplatin
- Liposomal Doxorubicin
- Platinol-AQ
- Platinol
- CDDP
- Doxil
- Liposomal
- Doxorubicin Hydrochloride
- Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
