Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer

NCT ID: NCT00967291

Last Updated: 2012-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-06-30

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ifosfamide

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

Intervention Type: DRUG

mitomycin C

8 mg/mq on day 1 every 28 days

Intervention Type: DRUG

Other Intervention Names

HOLOXAN; Mutamycin

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Michele Reni

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Reni, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Scientifico H. San Raffaele

Locations

Istituto Scientifico H. San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

PACT-11

Identifier Type: OTHER

Identifier Source: secondary_id

2006-001163-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR0000642574

Identifier Type: -

Identifier Source: org_study_id