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

NCT00081549 | Unknown Phase 1

• 1 other identifier: C-726-02
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic Cancer; Neoplasms Pancreatic; Pancreas Cancer; Pancreas Neoplasms; Pancreatic Tumor; Pancreas Tumor; Unresectable; Metastatic; Refractory

Interventions

Aroplatin (Liposomal NDDP, L-NDDP) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aronex Pharmaceuticals: lead

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 15, 2004
• First Posted: April 20, 2004
• Last Updated: June 24, 2005

Record last verified: 2004-04