Phase 2
Completed N=143
Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Source: ClinicalTrials.gov NCT00091026 ↗Enrolled (actual)
143
Serious AEs
27.3%
Results posted
Nov 2013
Primary outcomePrimary: Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) — 21; 21 percentage of participants — p=0.22
Summary
This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) |
21; 21 | 0.22 |
| SECONDARY Progression-free Survival |
5.0; 5.1 | 0.95 |
| SECONDARY Overall Survival |
7.9; 7.1 | 0.86 |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Advanced disease
- Patients with locally advanced disease must have disease that extends outside the boundaries of a standard radiation port
- Not amenable to curative surgery or radiotherapy
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Pleural effusions and ascites are not considered measurable lesions
- No CNS disease, including primary brain tumors or brain metastasis
- No tumor invasion into the duodenum
- Performance status - ECOG 0-2
- More than 3 months
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- WBC ≥ 3,000/mm^3
- No history of bleeding diatheses
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT and SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- INR ≤ 1.5 (≤ 3 for patients on warfarin)
- No esophageal varices
- Creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 60 mL/min
- Urine protein 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function
- No other concurrent antiplatelet medications
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapies or agents
- No other concurrent investigational drugs
Data sourced from ClinicalTrials.gov (NCT00091026). 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. Informational only — not medical advice.