Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aronex Pharmaceuticals
Treatments:
bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)
Gemcitabine
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.