Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer (PACT-11)
RATIONALE: Drugs used in chemotherapy, such as mitomycin C and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving mitomycin C together with ifosfamide works in treating patients with metastatic pancreatic cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mitomycin and Ifosfamide (MI) as Salvage Therapy for Metastatic Pancreatic Adenocarcinoma: a Phase II Study.|
- Progression-free survival at 6 months [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]CT scan
- Toxicity [ Time Frame: monthly ] [ Designated as safety issue: Yes ]outpatient visit
- Progression-free survival [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]CT scan
- Overall survival [ Time Frame: monthly ] [ Designated as safety issue: No ]outpatient visit or phone interview
|Study Start Date:||March 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
- To assess the therapeutic activity of a mitomycin C and ifosfamide combination, in terms of progression-free survival rate at 6 months, in patients with metastatic stage IV adenocarcinoma of the pancreas.
OUTLINE: Patients receive mitomycin C IV on day 1 and ifosfamide IV on days 1-3. Courses repeat every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967291
|Istituto Scientifico H. San Raffaele|
|Milan, Italy, 20132|
|Principal Investigator:||Michele Reni, MD||Istituto Scientifico H. San Raffaele|