Clinical trial · Interventional
Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The protocol has been completed prematurely (e.g., due to poor accrual, insufficient drug supply, IND closure).
Summary
Brief summary (as posted)
Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial is studying how well erlotinib hydrochloride works in treating patients with pancreatic cancer that can be removed by surgery
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraductal Papillary Mucinous Neoplasm of the Pancreas | Pancreatic Intraductal Papillary Mucinous Neoplasm | ALIAS | 0.90 |
| Recurrent Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Pancreatic Cancer | Malignant Pancreatic Neoplasm |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (enzyme inhibitor therapy)
- description
- Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
- interventionNames
- Drug: erlotinib hydrochloride
- Procedure: conventional surgery
- Other: immunohistochemistry staining method
- Genetic: protein expression analysis
- Procedure: biopsy
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment
- timeFrame
- Pre-treatment and post-treatment
- description
- Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed IPMN histological diagnosis, endoscopic ultrasound fine needle aspiration (EUS-FNA) core biopsy tissue specimen with plan for pancreatic surgical resection; histological diagnosis should be within 6 months of entry into protocol * Patients must have adequate bone marrow function at study entry * White blood cell (WBC) \> 3,000 * Platelets \> 100,000/mm\^3 * Hemoglobin \> 10 g/dL * Plasma creatinine of \< 1.6 mg/dL * Total bilirubin \< 1.5 * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 1.5 x upper limit of normal * Patients with evidence of obstructive lung disease (forced expiratory volume in one second \[FEV1\] \< 80% predicted and FEV1/forced vital capacity \[FVC\] ratio \< 90% of predicted value) as the etiology of a low diffusing capacity will still be eligible as long as the chest radiograph or computed tomography (CT) does not demonstrate interstitial changes * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Women of child-bearing potential and men taking study drug must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * Ability to understand, as well as sign the written informed consent document * If a woman of child-bearing potential, must have a negative pregnancy test prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately Exclusion Criteria: * Intake of EGFR antagonist, Erbitux (cetuximab) * Previous history of sensitivity to Tarceva (erlotinib hydrochloride), Iressa (gefitinib), or Erbitux, such as a rash that is uncontrollable by topical steroids and/or antibiotics * Uncontrollable diarrhea of any cause * Active keratoconjunctivitis, or corneal surgery in the past three weeks * Participants taking a known cytochrome P450 3A4 (CYP 3A4) inducer (e.g., phenytoin, carbamazepine, St. John's wort, and rifampin) and medications known to be inhibitors or metabolized by CYP3A4; these inhibitors include erythromycin, clarithromycin and ketoconazole, and patients taking them will be excluded since these drugs may be expected to result in altered exposure of Erlotinib * Hospitalization within the past 5 years for mania or for bipolar disease * Participants may not be receiving any other investigational pharmaceutical agents * Women who are breast-feeding should not receive Erlotinib * Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation in and compliance to the study
References
Publications (1)
- RESULTArmstrong WB, Wan XS, Kennedy AR, Taylor TH, Meyskens FL Jr. Development of the Bowman-Birk inhibitor for oral cancer chemoprevention and analysis of Neu immunohistochemical staining intensity with Bowman-Birk inhibitor concentrate treatment. Laryngoscope. 2003 Oct;113(10):1687-702. doi: 10.1097/00005537-200310000-00007. PMID 14520092