Clinical trial · Interventional
Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer
NCT01010945CI-TRIAL-00082878completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced 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 |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib | Drug | Erlotinib | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- erlotinib, gemcitabine, nab-paclitaxel
- description
- Patients receive the following treatment in 28-day cycles: 1) erlotinib: orally once daily from days 1 through 28 continuous dosing; 2) gemcitabine (following nab-paclitaxel): intravenously over 30 minutes on days 1, 8 and 15 every 28 days; and 3) nab-paclitaxel: intravenously over 30 minutes on days 1, 8 and 15 every 28 days.
- interventionNames
- Drug: erlotinib
- Drug: gemcitabine
- Drug: nab-paclitaxel
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- Monthly (to a maximum of 12 months)
Secondary outcomes (6)
- measure
- Safety of drug combination assessed through dose limiting toxicities (DLTs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 * Predicted life expectancy of \>= 12 weeks * Previous surgery * Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma * No prior therapy for pancreatic cancer * Adequate organ and marrow function * Absolute neutrophil count \>= 1.5 x 10\^9/L * Platelets \>= 100 x 10\^9/L * Total bilirubin \<= institutional upper limits of normal * AST (SGOT)/ALT(SGPT) \<= 2 x institutional upper limits of normal * Serum creatinine \<= 1.5 x upper limits of normal * Negative pregnancy test * Informed consent * Patient must agree not to smoke while on study Exclusion Criteria: * Significant history of cardiac disease unless the disease is well controlled * Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study * History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent * History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline * Pregnant or breast-feeding females * Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days * History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs
References
Publications (0)
Data not yet available
No reference posted for this study.