Advanced Pancreatic Cancer
Conditions
Keywords
erlotinib, nab-paclitaxel, gemcitabine, Adenocarcinoma, Advanced Pancreatic Cancer, Phase 1b
Brief summary
This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.
Detailed description
This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.
Interventions
DRUGerlotinib
administered orally
DRUGgemcitabine
administered intravenously
DRUGnab-paclitaxel
administered intravenously
Sponsors
OSI Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose | Monthly (to a maximum of 12 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of drug combination assessed through Adverse Events (AEs) | Monthly (to a maximum of 12 months) | — |
| Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h) | Days 29 (Cycle 2, Day 1) and 30 | — |
| Safety of drug combination assessed through dose limiting toxicities (DLTs) | 1 month | — |
| Progression Free Survival (PFS) | Monthly (to a maximum of 12 months) | PFS will be calculated as the time from start of treatment until disease progression or death; patients who are still alive and free of progression at their last follow-up will be censored at that time. |
| Overall Survival | Monthly (to a maximum of 12 months) | Survival will be calculated as the time from start of treatment until death of any cause, patients who are still alive at their last follow-up will be censored at that time. |
| Objective Response Rate | Monthly (to a maximum of 12 months) | Response will be based on the RECIST v1.1 criteria. Patients with partial and complete response will be classified as responders. |
Countries
United States
Outcome results
None listed