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TerminatedNCT00967291PACT-11Updated Feb 1, 2012

Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer

A Phase 2 interventional study of ifosfamide and mitomycin C in Pancreatic Cancer, sponsored by IRCCS San Raffaele. Terminated at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-02-01.

Sponsored by IRCCS San Raffaele · Phase 2, Interventional, and Treatment

Why this study was terminated
lack of activity and G3-4 toxicity at interim analysis
Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • acinar cell adenocarcinoma of the pancreas
  • duct cell adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 21 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Interventions

  • Drugifosfamide

    2,500 mg/mq on days 1-3 every 28 days

    Also known as: HOLOXAN

  • Drugmitomycin C

    8 mg/mq on day 1 every 28 days

    Also known as: Mutamycin

06

What researchers measure

Primary outcomes

  1. Progression-free survival at 6 months

    CT scan

    Time frame: every 2 months during therapy; every 3 months thereafter

Secondary outcomes

  1. Toxicity

    outpatient visit

    Time frame: monthly

  2. Progression-free survival

    CT scan

    Time frame: every 2 months during therapy; every 3 months thereafter

  3. Overall survival

    outpatient visit or phone interview

    Time frame: monthly

07

Study locations

1 site
  • Istituto Scientifico H. San Raffaele
    Milan, 20132, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00967291
Lead sponsor
IRCCS San Raffaele
Responsible party
Michele Reni (MD, IRCCS San Raffaele) — Principal investigator
First posted
Aug 27, 2009
Start date
Mar 2006
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Feb 1, 2012

Study contacts

Michele Reni, MD
principal investigator · Istituto Scientifico H. San Raffaele

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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