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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 15, 2004
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00081549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies
Official Title ^ICMJE	A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer
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.
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 ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pancreatic Neoplasms
Intervention ^ICMJE	Drug: Aroplatin (Liposomal NDDP, L-NDDP)
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	111
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00081549
Other Study ID Numbers ^ICMJE	C-726-02
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Aronex Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Aronex Pharmaceuticals
Verification Date	April 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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