Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works as first-line therapy in treating patients with locally advanced or metastatic pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

OBJECTIVES: Primary * Evaluate the time to progression in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and imatinib mesylate as first-line therapy. Secondary * Assess the response rate in patients treated with this regimen. * Assess the percentage of patients treated with this regimen who survive 1 year or more. * Assess the toxicity of this regimen in these patients. * Assess the overall survival of patients treated with this regimen. OUTLINE: This is a multicenter, nonrandomized, open-label, uncontrolled study. Patients receive gemcitabine hydrochloride IV over 120 minutes on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression-free Survival [4 years]. Median, months (95% Confidence Interval). Gemcitabine and Imatinib (n=42): 3.9 (2.06 to 5.14).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Response Rate [5 years]. Number, percentage of total evaluable subjects (95% Confidence Interval). Gemcitabine and Imatinib (n=35): 48.6 (33.0 to 64.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

1-year Survival Rate [5 years]. Number, percentage of total evaluable subjects (95% Confidence Interval). Gemcitabine and Imatinib (n=42): 25.6 (13.8 to 39.1).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [5 years]. Median, months (95% Confidence Interval). Gemcitabine and Imatinib (n=42): 6.23 (5.15 to 8.46).