Clinical trial · Interventional
Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer
Mitomycin and Ifosfamide (MI) as Salvage Therapy for Metastatic Pancreatic Adenocarcinoma: a Phase II Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of activity and G3-4 toxicity at interim analysis
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ifosfamide | Drug | Ifosfamide | ALIAS |
| mitomycin C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival at 6 months
- timeFrame
- every 2 months during therapy; every 3 months thereafter
- description
- CT scan
Secondary outcomes (3)
- measure
- Toxicity
- timeFrame
- monthly
- description
- outpatient visit
- measure
- Progression-free survival
- timeFrame
- every 2 months during therapy; every 3 months thereafter
- description
- CT scan
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available