Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer (PACT-11)
This study has been terminated.
(lack of activity and G3-4 toxicity at interim analysis)
Sponsor:
IRCCS San Raffaele
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00967291
First received: August 26, 2009
Last updated: January 31, 2012
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: ifosfamide Drug: mitomycin C |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mitomycin and Ifosfamide (MI) as Salvage Therapy for Metastatic Pancreatic Adenocarcinoma: a Phase II Study. |
Resource links provided by NLM:
Further study details as provided by IRCCS San Raffaele:
Primary Outcome Measures:
- Progression-free survival at 6 months [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]CT scan
Secondary Outcome Measures:
- Toxicity [ Time Frame: monthly ] [ Designated as safety issue: Yes ]outpatient visit
- Progression-free survival [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]CT scan
- Overall survival [ Time Frame: monthly ] [ Designated as safety issue: No ]outpatient visit or phone interview
| Enrollment: | 21 |
| Study Start Date: | March 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: ifosfamide
2,500 mg/mq on days 1-3 every 28 days
Other Name: HOLOXAN
Drug: mitomycin C
8 mg/mq on day 1 every 28 days
Other Name: Mutamycin
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Michele Reni, MD, IRCCS San Raffaele |
| ClinicalTrials.gov Identifier: | NCT00967291 History of Changes |
| Other Study ID Numbers: | CDR0000642574, PACT-11, 2006-001163-29 |
| Study First Received: | August 26, 2009 |
| Last Updated: | January 31, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by IRCCS San Raffaele:
|
acinar cell adenocarcinoma of the pancreas duct cell adenocarcinoma of the pancreas stage IV pancreatic cancer recurrent pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Mitomycins |
Mitomycin Isophosphamide mustard Ifosfamide Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 22, 2013