Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer

Study Overview
=================
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.

Official Title
-----------------
Mitomycin and Ifosfamide (MI) as Salvage Therapy for Metastatic Pancreatic Adenocarcinoma: a Phase II Study.

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: ifosfamide
* Drug: mitomycin C


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas Stage IV disease Metastatic disease Prior treatment with gemcitabine-based chemotherapy, also in the adjuvant setting, with progression-free survival at ≤ 12 months Measurable disease according RECIST criteria No symptomatic brain metastases PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% (80-100% in patients > 70 years of age) Adequate bone marrow, liver, and kidney function Not pregnant or nursing No other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms with no evidence of disease ≥ 5 years No severe comorbidities that could compromise safety, including any of the following: Cardiac failure Cardiac arrhythmia Prior myocardial infarction within the past 4 months History of psychiatric disabilities PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior mitomycin C and ifosfamide No concurrent treatment with experimental drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ifosfamide|2,500 mg/mq on days 1-3 every 28 days|
|Drug: mitomycin C|8 mg/mq on day 1 every 28 days|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival at 6 months | CT scan | every 2 months during therapy; every 3 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | outpatient visit | monthly | 
| Progression-free survival | CT scan | every 2 months during therapy; every 3 months thereafter | 
| Overall survival | outpatient visit or phone interview | monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acinar cell adenocarcinoma of the pancreas, duct cell adenocarcinoma of the pancreas, stage IV pancreatic cancer, recurrent pancreatic cancer