Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PACT-11  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00967291
• Other study ID #: CDR0000642574
• Secondary ID: PACT-112006-0011
• Status: Terminated
• Phase: Phase 2
• First received: August 26, 2009
• Last updated: January 31, 2012
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: August 2009
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• ifosfamide
2,500 mg/mq on days 1-3 every 28 days
• mitomycin C
8 mg/mq on day 1 every 28 days

Locations

Country	Name	City	State
Italy	Istituto Scientifico H. San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival at 6 months	CT scan	every 2 months during therapy; every 3 months thereafter	No
Secondary	Toxicity	outpatient visit	monthly	Yes
Secondary	Progression-free survival	CT scan	every 2 months during therapy; every 3 months thereafter	No
Secondary	Overall survival	outpatient visit or phone interview	monthly	No