NCT00967291

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
Last Updated

February 1, 2012

Status Verified

August 1, 2009

Enrollment Period

2.3 years

First QC Date

August 26, 2009

Last Update Submit

January 31, 2012

Conditions

Pancreatic Cancer

Keywords

acinar cell adenocarcinoma of the pancreasduct cell adenocarcinoma of the pancreasstage IV pancreatic cancerrecurrent pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival at 6 months

    CT scan

    every 2 months during therapy; every 3 months thereafter

Secondary Outcomes (3)

  • Toxicity

    monthly

  • Progression-free survival

    every 2 months during therapy; every 3 months thereafter

  • Overall survival

    monthly

Interventions

ifosfamideDRUG

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

Also known as: HOLOXAN
mitomycin CDRUG

8 mg/mq on day 1 every 28 days

Also known as: Mutamycin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

IfosfamideMitomycin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMitomycinsIndolequinonesQuinonesAzirinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Michele Reni, MD

    Istituto Scientifico H. San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

March 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 1, 2012

Record last verified: 2009-08

Locations

IT(1)