A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Overview
- Phase
- Phase 3
- Intervention
- Erlotinib
- Conditions
- Pancreatic Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 80
- Primary Endpoint
- Percentage of Participants With Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease
- •No prior systemic treatment for metastatic disease
- •Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- •Life expectancy ≥12 weeks
- •Adequate hematologic, hepatic, and renal function
- •Negative pregnancy test within 72 hours of study drug and use of effective contraception among women of childbearing potential
Exclusion Criteria
- •Unstable systemic disease
- •Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth factor receptor (EGFR) inhibitors
- •Other malignancy within 5 years prior to study entry
- •Significant opthalmologic abnormality
- •Inability to take oral medication
- •Need for IV alimentation
- •Prior surgery affecting absorption
- •Active peptic ulcer disease
- •Nursing mothers
Arms & Interventions
Erlotinib + Gemcitabine
Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
Intervention: Erlotinib
Erlotinib + Gemcitabine
Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 40 months (assessed continuously during treatment)
An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.
Secondary Outcomes
- European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores(Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study))
- Overall Survival (OS)(Up to approximately 40 months (assessed continuously through end of study))
- Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)(Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study))
- Progression-Free Survival (PFS) According to RECIST(Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study))
- Percentage of Participants Who Died(Up to approximately 40 months (assessed continuously through end of study))