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

NCT00507962 | Completed Phase 1

• 1 other identifier: 2004-0568
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancer

Keywords

Advanced Cancer; Dominant Liver Involvement; Hepatic Intraarterial Cisplatin; Cisplatin; Liposomal Doxorubicin; Platinol-AQ; Platinol; CDDP; Doxil; Liposomal; Doxorubicin Hydrochloride

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  Dose level at which no dose limiting toxicities are seen for a monthly cytotoxic regimen combining intraarterial hepatic cisplatin with systemic intravenous liposomal doxorubicin.

  With each 4 week cycle (28 days)

Study Arms (1)

Cisplatin + Liposomal Doxorubicin

EXPERIMENTAL

Cisplatin 100 mg/m\^2 Intraarterial and Liposomal Doxorubicin starting dose 20 mg/m\^2 by vein on Day 1 every 4 weeks

Drug: Cisplatin; Drug: Liposomal Doxorubicin

Interventions

Cisplatin DRUG

100 mg/m\^2 Intraarterial On Day 1 Every 4 Weeks

Also known as: Platinol-AQ, Platinol, CDDP

Cisplatin + Liposomal Doxorubicin

Liposomal Doxorubicin DRUG

Starting dose 20 mg/m\^2 IV On Day 1 Every 4 Weeks

Also known as: Doxil, Liposomal, Doxorubicin Hydrochloride

Cisplatin + Liposomal Doxorubicin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Interventions

Cisplatin; liposomal doxorubicin; Liposomes; Doxorubicin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Apostolia Tsimberidou, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 27, 2007
• Study Start: March 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)