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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6 months

Outcome Description:

CT scan

Outcome Time Frame:

every 2 months during therapy; every 3 months thereafter

Safety Issue:

No

Principal Investigator

Michele Reni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Scientifico H. San Raffaele

Authority:

Italy: Ministry of Health

Study ID:

CDR0000642574

NCT ID:

NCT00967291

Start Date:

March 2006

Completion Date:

June 2008

Related Keywords:

  • Pancreatic Cancer
  • acinar cell adenocarcinoma of the pancreas
  • duct cell adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

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