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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
  Purpose

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 Intervention Phase
Pancreatic Neoplasms
Drug: Aroplatin (Liposomal NDDP, L-NDDP)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 NLM:


Further study details as provided by Aronex Pharmaceuticals:

Estimated Enrollment: 111
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00081549     History of Changes
Other Study ID Numbers: C-726-02
Study First Received: April 15, 2004
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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 Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014