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

Aronex Pharmaceuticals

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Pancreatic Neoplasms

Treatments

Drug: Aroplatin (Liposomal NDDP, L-NDDP)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00081549

C-726-02

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.