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

This study has been terminated.
(lack of activity and G3-4 toxicity at interim analysis)
Sponsor:
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00967291
First received: August 26, 2009
Last updated: January 31, 2012
Last verified: August 2009
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: ifosfamide
Drug: mitomycin C
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mitomycin and Ifosfamide (MI) as Salvage Therapy for Metastatic Pancreatic Adenocarcinoma: a Phase II Study.

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]
    CT scan


Secondary Outcome Measures:
  • Toxicity [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
    outpatient visit

  • Progression-free survival [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]
    CT scan

  • Overall survival [ Time Frame: monthly ] [ Designated as safety issue: No ]
    outpatient visit or phone interview


Enrollment: 21
Study Start Date: March 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967291

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

Additional Information:
No publications provided

Responsible Party: Michele Reni, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT00967291     History of Changes
Other Study ID Numbers: CDR0000642574, PACT-11, 2006-001163-29
Study First Received: August 26, 2009
Last Updated: January 31, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by 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:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Mitomycins
Mitomycin
Isophosphamide mustard
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on August 01, 2014