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Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer (PACT-11)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Michele Reni, 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: ifosfamide Drug: mitomycin C Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Intervention Details:
  • Drug: ifosfamide
    2,500 mg/mq on days 1-3 every 28 days
    Other Name: HOLOXAN
  • Drug: mitomycin C
    8 mg/mq on day 1 every 28 days
    Other Name: Mutamycin

Primary Outcome Measures :
  1. Progression-free survival at 6 months [ Time Frame: every 2 months during therapy; every 3 months thereafter ]
    CT scan

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: monthly ]
    outpatient visit

  2. Progression-free survival [ Time Frame: every 2 months during therapy; every 3 months thereafter ]
    CT scan

  3. Overall survival [ Time Frame: monthly ]
    outpatient visit or phone interview

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • No prior mitomycin C and ifosfamide
  • No concurrent treatment with experimental drugs

Information from the National Library of Medicine

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 identifier (NCT number): NCT00967291

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Istituto Scientifico H. San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
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Principal Investigator: Michele Reni, MD Istituto Scientifico H. San Raffaele

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Responsible Party: Michele Reni, MD, IRCCS San Raffaele Identifier: NCT00967291     History of Changes
Other Study ID Numbers: CDR0000642574
PACT-11 ( Other Identifier: IRCCS San Raffaele )
2006-001163-29 ( EudraCT Number )
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: August 2009
Keywords provided by Michele Reni, IRCCS San Raffaele:
acinar cell adenocarcinoma of the pancreas
duct cell adenocarcinoma of the pancreas
stage IV pancreatic cancer
recurrent pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Isophosphamide mustard
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors