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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00081549
• Other study ID #: C-726-02
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 15, 2004
• Last updated: June 23, 2005

Study information

• Verified date: April 2004
• Source: Aronex Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 111
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• Aroplatin (Liposomal NDDP, L-NDDP)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aronex Pharmaceuticals