Clinical trial NCT00081549: Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies
Official title: A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pancreatic Neoplasms
Keywords: Pancreatic Cancer
Neoplasms Pancreatic
Pancreas Cancer
Pancreas Neoplasms
Pancreatic Tumor
Pancreas Tumor
Unresectable
Metastatic
Refractory
Lead sponsor: Aronex Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-04-20
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

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Secondary outcomes:
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