Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer (PACT-11)
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|ClinicalTrials.gov Identifier: NCT00967291|
Recruitment Status : Terminated (lack of activity and G3-4 toxicity at interim analysis)
First Posted : August 27, 2009
Last Update Posted : February 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: ifosfamide Drug: mitomycin C||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mitomycin and Ifosfamide (MI) as Salvage Therapy for Metastatic Pancreatic Adenocarcinoma: a Phase II Study.|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
- Drug: ifosfamide
2,500 mg/mq on days 1-3 every 28 daysOther Name: HOLOXAN
- Drug: mitomycin C
8 mg/mq on day 1 every 28 daysOther Name: Mutamycin
- Progression-free survival at 6 months [ Time Frame: every 2 months during therapy; every 3 months thereafter ]CT scan
- Toxicity [ Time Frame: monthly ]outpatient visit
- Progression-free survival [ Time Frame: every 2 months during therapy; every 3 months thereafter ]CT scan
- Overall survival [ Time Frame: monthly ]outpatient visit or phone interview
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967291
|Istituto Scientifico H. San Raffaele|
|Milan, Italy, 20132|
|Principal Investigator:||Michele Reni, MD||Istituto Scientifico H. San Raffaele|