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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
ifosfamide
mitomycin C
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring acinar cell adenocarcinoma of the pancreas, duct cell adenocarcinoma of the pancreas, stage IV pancreatic cancer, recurrent pancreatic cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Scientifico H. San Raffaele

Outcomes

Primary Outcome Measures

Progression-free survival at 6 months
CT scan

Secondary Outcome Measures

Toxicity
outpatient visit
Progression-free survival
CT scan
Overall survival
outpatient visit or phone interview

Full Information

First Posted
August 26, 2009
Last Updated
January 31, 2012
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT00967291
Brief Title
Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer
Acronym
PACT-11
Official Title
Mitomycin and Ifosfamide (MI) as Salvage Therapy for Metastatic Pancreatic Adenocarcinoma: a Phase II Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
lack of activity and G3-4 toxicity at interim analysis
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
acinar cell adenocarcinoma of the pancreas, duct cell adenocarcinoma of the pancreas, stage IV pancreatic cancer, recurrent pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ifosfamide
Other Intervention Name(s)
HOLOXAN
Intervention Description
2,500 mg/mq on days 1-3 every 28 days
Intervention Type
Drug
Intervention Name(s)
mitomycin C
Other Intervention Name(s)
Mutamycin
Intervention Description
8 mg/mq on day 1 every 28 days
Primary Outcome Measure Information:
Title
Progression-free survival at 6 months
Description
CT scan
Time Frame
every 2 months during therapy; every 3 months thereafter
Secondary Outcome Measure Information:
Title
Toxicity
Description
outpatient visit
Time Frame
monthly
Title
Progression-free survival
Description
CT scan
Time Frame
every 2 months during therapy; every 3 months thereafter
Title
Overall survival
Description
outpatient visit or phone interview
Time Frame
monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Reni, MD
Organizational Affiliation
Istituto Scientifico H. San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Scientifico H. San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

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Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer

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