Phase 2
N=44
Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00161213 ↗Enrolled (actual)
44
Serious AEs
14.0%
Results posted
Dec 2012
Primary outcome: Primary: Progression-free Survival — 3.9 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- gemcitabine hydrochloride (Drug); imatinib mesylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Medicine and Dentistry of New Jersey
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
3.9 | — |
| SECONDARY Response Rate |
48.6 | — |
| SECONDARY 1-year Survival Rate |
25.6 | — |
| SECONDARY Overall Survival |
6.23 | — |
Summary
RATIONALE: 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. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works as first-line therapy in treating patients with locally advanced or metastatic pancreatic cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma (originating in the pancreas)
- Locally advanced or metastatic disease
- Not eligible for curative resection
- Must have measurable or evaluable disease as defined by RECIST criteria
- No CA19-9 elevation as only evidence of disease
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 125,000/mm³
- Bilirubin 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer
- Prior fluorouracil as a radiosensitizing agent allowed
- At least 4 weeks since prior radiotherapy and recovered
- Must have evidence of disease outside the radiation fields OR radiologically confirmed disease progression within the radiation fields after completion of radiotherapy
- No concurrent therapeutic warfarin
- Prophylactic warfarin ≤ 1 mg daily allowed for prophylaxis of central venous catheter thrombosis
- Low molecular weight heparin or heparin allowed for anticoagulation
- No concurrent chronic systemic corticosteroids
- No other concurrent agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, or cancer surgery
- No other concurrent experimental medications
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Data sourced from ClinicalTrials.gov (NCT00161213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.