Clinical trial · Interventional
Imatinib Mesylate and Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Pancreatic Cancer
Phase I/II Study of Gleevec (Imatinib Mesylate, Formerly Known as STI571) and Gemcitabine for Advanced Pancreas Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed to accrual to allow enrollment on another more promising trial.
Summary
Brief summary (as posted)
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with gemcitabine may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving imatinib mesylate together with gemcitabine and to see how well they work in treating patients with locally advanced, metastatic, or recurrent 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 |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Determine maximum tolerated dose according to toxicity
- timeFrame
- After 1 cycle of therapy (1 cycle = 21 days)
- measure
- Clinical response rate
- timeFrame
- After every 2 cycles of study therapy (1 cycle = 21 days)
- measure
- Overall survival at 6 months
- timeFrame
- After 6 months of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed pancreatic cancer * Locally advanced, metastatic, or recurrent disease * Measurable or evaluable disease by physical exam, plain radiographs, CT scan, or MRI * No brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy of 12 weeks or greater * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 2.5 times ULN (5 times ULN if liver metastases are present) * No chronic liver disease (i.e., chronic active hepatitis or cirrhosis) * Creatinine ≤ 2.0 mg/dL * No chronic renal disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier-method contraception during and for ≥ 3 months after completion of study treatment * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * No uncontrolled diabetes * No active uncontrolled infection * No other severe and/or uncontrolled medical disease * HIV negative PRIOR CONCURRENT THERAPY: * No prior therapy for metastatic disease * Prior fluorouracil as a radiosensitizer for adjuvant therapy after surgery or for locally advanced disease is permitted if local disease has recurred or progressed ≥ 3 months after completion of therapy or disease is present outside the radiation field * At least 2 weeks since prior major surgery * No concurrent grapefruit or grapefruit juice
References
Publications (0)
Data not yet available