Aroplatin And Gemcitabine In Patients With Advanced Pancreatic Cancer Resistant To Standard Therapies

Study Overview

Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies

This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase II, the primary objective is to evaluate survival after therapy with Aroplatin and gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

Phase I Primary Objective: * Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Phase II Primary Objective: * Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Phase II Secondary Objective: * Evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

Pancreatic Neoplasms

DRUG: Aroplatin (Liposomal NDDP, L-NDDP)

C-726-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2004-04-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2005-06-23
First Submitted that Met QC Criteria 2004-04-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2005-06-24
First Posted (ESTIMATED) 2004-04-20	Results First Posted N/A	Last Verified 2004-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Crossover

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pancreatic cancer (AJCC Stage II-IV);
Unresectable cancer;
Measurable disease (RECIST criteria);
No prior therapy;
ECOG Score 0-2
Life expectancy greater then or equal to three months;
Adequate hematopoietic, liver and renal function;
Women of child-bearing potential must have negative urine/serum pregnancy test;
Signed written informed consent;
Subjects must be willing to be followed during the course of the treatment/observation and follow-up.

Prior therapy for pancreatic cancer;
Previously diagnosed brain metastases if symptomatic and requiring active therapy;
Other cancers within the last five years, with the exception of adequately treated cone-biopsied in-situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study
Primary or secondary immunodeficiency, or use of corticosteroids immunosuppressive medication;
Women must not be pregnant or breast-feeding;
Participation in any clinical trial involving investigational drugs within one month from enrollment into the present study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record