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A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies



A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies

For Condition: Esophageal Neoplasms,Colorectal Neoplasms,Neoplasms,Ovarian Neoplasms,Pancreatic Neoplasms,Hepatocellular Carcinoma
Status: No longer recruiting
Sponsor(s): Aronex Pharmaceuticals ,
Synopsis: To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.
Details: Primary Objective: - Determine response rate (RR; complete and partial response [CR, PR]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies. Secondary Odjective: - Determine the safety and tolerability of Aroplatin
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Advanced solid malignancies; - Amenable to therapy with DACH platinum agents; - Measurable disease (RECIST criteria); - ECOG performance score of 0-2; - Adequate hematopoietic, liver and renal function; - Adequate cardiac function (maximum of class II, NYHA); - Women of childbearing potential must have a negative urine or serum pregnancy test; - Signed written informed consent; - Subjects must be willing to be followed during the course of treatment/observation and follow-up. Exclusion Criteria: - No other active malignancies; - No prior therapy with oxaliplatin; - No known brain metastases; - Active, uncontrolled infection or other serious medical illnesses; - Not using or have used any investigational therapy during four weeks before start of protocol treatment.
Total Enrollment: 40

Location and Contact Information:

John Wayne Cancer Institute
Santa Monica,  California,  90404
United States
 


Additional Information:
Study ID Numbers:  C-726-04; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057395

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