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

Phase 1

• Conditions: Pancreatic Neoplasms

• Registration Number: NCT00081549
• Lead Sponsor: Aronex Pharmaceuticals

Brief Summary

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.

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 Timeline

• Status Verified: 2004-04
• Study First Submitted: 2004-04-15
• Study First Submitted QC: 2004-04-19
• Study First Posted: 2004-04-20
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER