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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neoplasms

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

C-726-02

NCT ID:

NCT00081549

Start Date:

Completion Date:

Related Keywords:

  • Pancreatic Neoplasms
  • Pancreatic Cancer
  • Neoplasms Pancreatic
  • Pancreas Cancer
  • Pancreas Neoplasms
  • Pancreatic Tumor
  • Pancreas Tumor
  • Unresectable
  • Metastatic
  • Refractory
  • Neoplasms
  • Pancreatic Neoplasms

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