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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by Aronex Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Aronex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00081549
First received: April 15, 2004
Last updated: June 23, 2005
Last verified: April 2004

April 15, 2004
June 23, 2005
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Complete list of historical versions of study NCT00081549 on ClinicalTrials.gov Archive Site
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Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies
A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer

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 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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Neoplasms
Drug: Aroplatin (Liposomal NDDP, L-NDDP)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
111
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00081549
C-726-02
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Aronex Pharmaceuticals
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Aronex Pharmaceuticals
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP