Pancreatic Cancer
Conditions
Keywords
acinar cell adenocarcinoma of the pancreas, duct cell adenocarcinoma of the pancreas, stage IV pancreatic cancer, recurrent pancreatic cancer
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.
Interventions
DRUGifosfamide
2,500 mg/mq on days 1-3 every 28 days
DRUGmitomycin C
8 mg/mq on day 1 every 28 days
Sponsors
IRCCS San Raffaele
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival at 6 months | every 2 months during therapy; every 3 months thereafter | CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | monthly | outpatient visit |
| Progression-free survival | every 2 months during therapy; every 3 months thereafter | CT scan |
| Overall survival | monthly | outpatient visit or phone interview |
Countries
Italy
Outcome results
None listed