Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer (PACT-11)

San Donato Group (GSD)

Status and phase: Terminated; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: ifosfamide; Drug: mitomycin C

Study type: Interventional

Funder types: Other

Identifiers

NCT00967291

2006-001163-29 (EudraCT Number)

PACT-11 (Other Identifier)

CDR0000642574

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)