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

January 31, 2012 updated by: Michele Reni, IRCCS San Raffaele

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Istituto Scientifico H. San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000642574
  • PACT-11 (Other Identifier: IRCCS San Raffaele)
  • 2006-001163-29 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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