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A Phase I/II Single Dose Trial to Determine The Safety, Tolerance, Pharmacokinetic Profile, and Preliminary Activity of Intrahepatic Delivery (Via Hepatic Artery Catheterization) of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers ( MTC-DOX) in Patients With Metastatic Cancer to the Liver .


Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Both
Metastases, Neoplasm, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Breast Neoplasms, Melanoma, Sarcoma, Gastrointestinal Neoplasms, Lung Neoplasms, Liver Neoplasms, Cholangiocarcinoma

Thank you

Trial Information

A Phase I/II Single Dose Trial to Determine The Safety, Tolerance, Pharmacokinetic Profile, and Preliminary Activity of Intrahepatic Delivery (Via Hepatic Artery Catheterization) of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers ( MTC-DOX) in Patients With Metastatic Cancer to the Liver .

Inclusion Criteria


Inclusion Criteria

- Patients with a Karnofsky (or equivalent) performance status > 60 and an expected
survival of > 2 months

- Patients agreeing to use a medically effective method of contraception

- Patients able to understand and give written informed consent

- The center of the tumor mass must be < or = 14 cm from the anterior or lateral
abdominal wall as determined by cross sectional imaging measured at baseline. This is
required for optimal retention of MTC-DOX by the magnetic field. If more than one
tumor mass is present, all of the treated tumor masses must meet this criterion

Exclusion Criteria

- Women who are pregnant or lactating

- Patient’s with metastatic liver cancer, or other primary liver cancer excluding HCC,
with diffuse disease that does not have focal area(s) conducive to local regional
therapy

- Patients with the following laboratory abnormalities:Hemoglobin < 10.0
g/dL;Granulocyte count < 1,500 per mm3;Platelet count < 50,000 per mm3; Lymphocyte
count < 0.5 x 10 to the 9th per L; Total bilirubin >/= 3.0 mg/dL;AST or ALT >/= 5x
the upper limit of normal;INR >/= 1.3; Creatinine >/= 2.0 mg/dL

- Patients with either significant cardiovascular disease or any other organ system
dysfunction which, in the opinion of the investigator, would either compromise the
patient's safety or interfere with the evaluation of the test material. Patients
with evidence of a myocardial infarction within six (6) months prior to this trial
will be excluded.

- Patients with an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other
indwelling device or appliance that could be adversely affected by the use of the
external magnet

- Patients at the time of study entry with a second invasive cancer other than basal
cell and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix

- Patients with documented evidence of hemachromatosis or hemosiderosis

- Patients with CT or ultrasound evidence of portal vein invasion or thrombosis

- Patients who have had prior anthracycline therapy with a left ventricular ejection
fraction (LVEF) <50%, as measured by either multigated radionuclide angiography
(MUGA) scan or echocardiogram.

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

Principal Investigator

Joy Koda, PhD

Investigator Role:

Study Chair

Authority:

United States: Food and Drug Administration

Study ID:

MTC-DOX-003

NCT ID:

NCT00041808

Start Date:

July 2001

Completion Date:

April 2003

Related Keywords:

  • Metastases, Neoplasm
  • Colorectal Neoplasms
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Breast Neoplasms
  • Melanoma
  • Sarcoma
  • Gastrointestinal Neoplasms
  • Lung Neoplasms
  • Liver Neoplasms
  • Cholangiocarcinoma
  • Metastatic liver cancer
  • Cholangiocarcinoma
  • colorectal cancer
  • esophageal cancer
  • gastric cancer
  • pancreatic cancer
  • breast cancer
  • malignant melanoma
  • sarcoma
  • GIST
  • gastrointestinal stromal tumor
  • lung cancer
  • liver cancer
  • Breast Neoplasms
  • Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Pancreatic Neoplasms
  • Cholangiocarcinoma
  • Sarcoma

Name

Location

Scott and White ClinicTemple, Texas  76508
Scripps Stevens Cancer DivisionSan Diego, California  92037
UCSF Cancer CenterSan Francisco, California  94143