Phase 2
N=94
Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00042939 ↗Enrolled (actual)
94
Serious AEs
78.0%
Results posted
Jul 2011
Primary outcome: Primary: Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria) — 0.045; 0.07 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cetuximab (Biological); docetaxel (Drug); irinotecan hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria) |
0.045; 0.07 | — |
| SECONDARY Progression-free Survival |
3.9; 4.5 | — |
| SECONDARY Overall Survival |
6.5; 5.3 | — |
| SECONDARY Epidermal Growth Factor Receptor (EGFR) Status |
29; 30; 1; 1 | — |
| SECONDARY Proportion of Patients With Thromboembolic Events |
0; 0.023 | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed metastatic adenocarcinoma of the pancreas
- Sufficient tumor tissue from fine needle aspiration, core biopsy, or open biopsy available for epidermal growth factor receptor testing
- At least 1 unidimensionally measurable primary or metastatic lesionge
- Age of 18 and over
- ECOG performance status 0-1
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine clearance > 60 mL/min
- LVEF normal
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Bilirubin ≤ upper limit of normal (ULN)*
- SGOT or SGPT and alkaline phosphatase must meet the criteria for 1 of the following*:
- SGOT or SGPT ≤ 2.5 times ULN AND alkaline phosphatase ≤ ULN
- SGOT or SGPT ≤ 1.5 times ULN AND alkaline phosphatase > ULN but ≤ 2.5 times ULN
- SGOT or SGPT ≤ ULN AND alkaline phosphatase > 2.5 but ≤ 4 times ULN
NOTE: *Percutaneous stenting or endoscopic retrograde cholangiopancreatography may be used to normalize liver function tests
Exclusion Criteria
- History of uncontrolled arrhythmias
- History of congestive heart failure
- History of uncontrolled angina pectoris
- Prior chemotherapy
- Pre-existing neuropathy ≥ grade 2
- Prior hypersensitivity to polysorbate 80
- Pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT00042939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.