Clinical trial NCT00967291: Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer
Official title: Mitomycin and Ifosfamide (MI) as Salvage Therapy for Metastatic Pancreatic Adenocarcinoma: a Phase II Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: acinar cell adenocarcinoma of the pancreas
duct cell adenocarcinoma of the pancreas
stage IV pancreatic cancer
recurrent pancreatic cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free survival at 6 months
timeFrame: every 2 months during therapy; every 3 months thereafter
Secondary outcomes:
measure: Toxicity
timeFrame: monthly
measure: Progression-free survival
timeFrame: every 2 months during therapy; every 3 months thereafter
measure: Overall survival
timeFrame: monthly
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Scientifico H. San Raffaele
Study officials:
affiliation: Istituto Scientifico H. San Raffaele
name: Michele Reni, MD
role: PRINCIPAL_INVESTIGATOR
References: