Clinical trial NCT01010945: Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
Official title: A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Pancreatic Cancer
Keywords: erlotinib
nab-paclitaxel
gemcitabine
Adenocarcinoma
Advanced Pancreatic Cancer
Phase 1b
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: Monthly (to a maximum of 12 months)
Secondary outcomes:
measure: Safety of drug combination assessed through dose limiting toxicities (DLTs)
timeFrame: 1 month
measure: Safety of drug combination assessed through Adverse Events (AEs)
timeFrame: Monthly (to a maximum of 12 months)
measure: Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h)
timeFrame: Days 29 (Cycle 2, Day 1) and 30
measure: Objective Response Rate
timeFrame: Monthly (to a maximum of 12 months)
measure: Progression Free Survival (PFS)
timeFrame: Monthly (to a maximum of 12 months)
measure: Overall Survival
timeFrame: Monthly (to a maximum of 12 months)
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Desert Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Monitor
role: STUDY_DIRECTOR
References: