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

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ClinicalTrials.gov Identifier: NCT00081549
Recruitment Status : Unknown
Verified April 2004 by Aronex Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : April 20, 2004
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Aronex Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: Aroplatin (Liposomal NDDP, L-NDDP) Phase 1 Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine
U.S. FDA Resources





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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

ClinicalTrials.gov Identifier: NCT00081549     History of Changes
Other Study ID Numbers: C-726-02
First Posted: April 20, 2004    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2004

Keywords provided by Aronex Pharmaceuticals:
Pancreatic Cancer
Neoplasms Pancreatic
Pancreas Cancer
Pancreas Neoplasms
Pancreatic Tumor
Pancreas Tumor
Unresectable
Metastatic
Refractory

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs