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

June 23, 2005 updated by: Aronex Pharmaceuticals

A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

111

Phase

  • Phase 2
  • Phase 1

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Aronex Pharmaceuticals

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

First Submitted

April 15, 2004

First Submitted That Met QC Criteria

April 19, 2004

First Posted (Estimate)

April 20, 2004

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-726-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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