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Chemotherapy in Treating Patients With Liver Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Matrix Pharmaceutical
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003044
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who have primary liver cancer that cannot be removed during surgery.


Condition Intervention Phase
Liver Cancer
Drug: cisplatin-e therapeutic implant
Phase II

MedlinePlus related topics:   Cancer    Liver Cancer   

ChemIDplus related topics:   Cisplatin    Epinephrine    Epinephrine bitartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Two-Stage Phase II Safety and Efficacy Study of IntraDose (Cisplatin/Epinephrine) Injectable Gel (MPI 5010) Administered to Patients With Unresectable Primary Hepatocellular Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   55
Study Start Date:   September 1996

Detailed Description:

OBJECTIVES: I. Evaluate the safety and efficacy of cisplatin-epinephrine injectable gel (Intradose MPI-5010) in patients with unresectable primary hepatocellular carcinoma.

OUTLINE: This is an open label, two stage, multicenter study. Patients receive intratumoral treatment with ciplatin-epinephrine (MPI-5010) once weekly, for up to four treatments within a six week period, followed by an evaluation two weeks after last treatment. Immediately after the first course, an optional second course of treatment may be undertaken at the discretion of the investigator. Patients with a complete response, partial response, and/or an increase in necrosis of at least 30% of total treated tumor volume will be followed monthly for up to 6 months. At the completion of 6 months follow up or following documentation of disease progression or development of new tumors, patients are monitored for survival in an extended follow up period. All nonresponders at the last 2 week posttreatment evaluation are entered in the extended follow up and monitored monthly for survival.

PROJECTED ACCRUAL: Up to 55 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven unresectable primary hepatocellular carcinoma No major vessel involvement Disease must be confined to the liver (no extrahepatic disease) Patients have no more than 3 tumors, with no tumor exceeding 7 cm in diameter, and the sum total tumor volume less than 200 cm3

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 40-100% Life Expectancy: At least 4 months Hematopoietic: Hemoglobin at least 10 g/dL Platelet count at least 75,000/mm3 Absolute granulocyte count at least 1,000/mm3 PT within 3 seconds of institutional norm Hepatic: SGPT no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Child-Pugh grade A or B Albumin at least 25 g/L Bilirubin no greater than 2.98 mg/dL Absent or easily controlled ascites not requiring routine or intermittent paracentesis Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.3 times ULN OR Creatinine clearance at least 45 mL/min Cardiovascular: No coronary artery disease No New York Heart Association class III or greater cardiac symptoms Other: Not pregnant or nursing No medical or psychiatric condition compromising informed consent No obesity or tumor location that would limit adequate tumor imaging No history of bleeding from liver tumor(s) or gastroesophageal bleeding No known hypersensitivity to cisplatin, bovine collagen, epinephrine, sulfites or radiographic contrast agents No history of encephalopathy

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for hepatocellular carcinoma No concurrent immunomodulating agents Chemotherapy: No prior or concurrent chemotherapy for hepatocellular carcinoma No concurrent cytotoxic agents Endocrine therapy: No prior endocrine therapy for hepatocellular carcinoma Radiotherapy: No prior radiotherapy for hepatocellular carcinoma Surgery: Prior surgical resection of the liver allowed Other: No concurrent use of aspirin, nonsteroidal anti-inflammatory agents, anticoagulants including warfarin sodium (Coumadin), and epinephrine containing medications including topical anesthetics such as bupivacaine HCl No prior investigational agents within 4 weeks of study No concurrent use of probenecid or thiazides Concurrent use of analgesics and antiemetics is allowed Concurrent use of topical and other local anesthetics, locoregional nerve blocks, and systemic agents is allowed

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003044

Locations
United States, Maryland
Johns Hopkins Oncology Center    
      Baltimore, Maryland, United States, 21287
United States, Minnesota
Mayo Clinic Cancer Center    
      Rochester, Minnesota, United States, 55905
Hong Kong
Prince of Wales Hospital    
      Shatin, New Territories, Hong Kong

Sponsors and Collaborators
Matrix Pharmaceutical

Investigators
Study Chair:     Richard D. Leavitt, MD     Matrix Pharmaceutical    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065675, MP-417-96-2, NCI-V97-1290
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003044
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized unresectable adult primary liver cancer  

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Carcinoma
Liver Neoplasms
Digestive System Diseases
Cisplatin
Gastrointestinal Neoplasms
Adenocarcinoma
Epinephrine
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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