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Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer

Phase 2
Terminated
Conditions
Pancreatic Cancer
Registration Number
NCT00967291
Lead Sponsor
IRCCS San Raffaele
Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
21
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Progression-free survival at 6 monthsevery 2 months during therapy; every 3 months thereafter

CT scan

Secondary Outcome Measures
NameTimeMethod
Toxicitymonthly

outpatient visit

Progression-free survivalevery 2 months during therapy; every 3 months thereafter

CT scan

Overall survivalmonthly

outpatient visit or phone interview

Trial Locations

Locations (1)

Istituto Scientifico H. San Raffaele

🇮🇹

Milan, Italy

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