Mitomycin C And Ifosfamide In Treating Patients With Metastatic Pancreatic Cancer

Study Overview

Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer

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.

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.

Pancreatic Cancer

DRUG: ifosfamide
DRUG: mitomycin C

CDR0000642574
PACT-11 (OTHER Identifier) (OTHER: IRCCS San Raffaele)
2006-001163-29 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-08-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-01-31
First Submitted that Met QC Criteria 2009-08-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-02-01
First Posted (ESTIMATED) 2009-08-27	Results First Posted N/A	Last Verified 2009-08

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

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

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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Michele Reni, MD, Istituto Scientifico H. San Raffaele

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record