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Home > "A" Clinical Trials Conditions > Aroplatin and Gemcitabine in Patients with Advanced Pancreatic Cancer Resistant to Standard Therapies  Aroplatin and Gemcitabine in Patients with Advanced Pancreatic Cancer Resistant to Standard Therapies
Aroplatin and Gemcitabine in Patients with Advanced Pancreatic Cancer Resistant to Standard Therapies
For Condition: Pancreatic Neoplasms
Status: No longer recruiting
Sponsor(s): Aronex Pharmaceuticals ,
Synopsis: 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.
Details: Phase I Primary Objective: - Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unreseactable, 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 folowed 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.
Total Enrollment: 111
Location and Contact Information:
Additional Information:
Study ID Numbers: C-726-02;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081549
Other Pancreatic Neoplasms Studies:
1. A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
2. A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
3. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
4. A multicenter phase 2 study of CI-1040 in patients with advanced nonsmall-cell lung cancer, breast cancer, colon cancer, or pancreatic cancer
5. Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer
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Aroplatin and Gemcitabine in Patients with Advanced Pancreatic Cancer Resistant to Standard Therapies
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