Clinical trial · Interventional
Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer
Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
NCT00470535CI-TRIAL-00026071terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was terminated earlier due to a phase III study that showed this drug inferior to sorafenib
Summary
Brief summary (as posted)
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with stage III or stage IV 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1 - Oral Erlotinib hydrochloride
- description
- Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity
- interventionNames
- Drug: erlotinib hydrochloride
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- Every cycle for up to 52 weeks
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Locally advanced inoperable or metastatic disease (stage III or IV disease) * No more than 1 prior systemic therapy * Patients who have not received 1 prior systemic therapy must meet 1 of the following criteria: * Ineligible for or refused chemoradiotherapy AND has stage III disease * Ineligible for or refused gemcitabine hydrochloride-based chemotherapy AND has stage IV disease * No brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * WBC \> 3,000/mm³ * ANC \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Bilirubin ≤ 2 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with documented liver metastases) * Creatinine \< 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study therapy * No uncontrolled comorbid illness that is likely to increase toxicity of the study drug or to interfere with toxicity evaluation * No known allergy to the study drug or its excipients * No symptomatic interstitial pulmonary disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior adjuvant therapy allowed provided it was completed at least 28 days prior to study entry * No prior EGFR-inhibitor * No concurrent drugs that are known to be strong inducers or inhibitors of the CYP450 enzyme system * No concurrent Hypericum perforatum (St. John's wort) * No concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.