Phase 2
N=104
Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00550836 ↗Enrolled (actual)
104
Serious AEs
62.0%
Results posted
Apr 2017
Primary outcome: Primary: Overall Survival — 4.2; 8.3 months — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- panitumumab (Biological); erlotinib hydrochloride (Drug); gemcitabine hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
4.2; 8.3 | 0.36 |
| SECONDARY Confirmed Response Rate |
0.087; 0.065 | 1.0 |
| SECONDARY Progression-free Survival |
2.0; 3.6 | 0.419 |
| SECONDARY Time to Treatment Failure |
2.0; 3.8 | 0.36 |
| SECONDARY Frequency and Severity of Observed Adverse Effects |
41; 41; 15; 14 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well giving panitumumab together with gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in treating patients with metastatic pancreatic cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas (ductal or undifferentiated)
- Metastatic disease
- No islet cell, acinar cell, or cystadenocarcinomas
- No locally advanced disease
- No history or known presence of CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2 times upper limit of normal (ULN) (patients may be stented)
- AST ≤ 2.5 times ULN
- Creatinine ≤ 2.0 times ULN
- Magnesium ≥ lower limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to provide a stool specimen
- No malignancy diagnosed within the past 3 years except basal cell or squamous cell skin cancer, prostate cancer (Gleason 6 months prior to study entry
- Adjuvant chemotherapy must not have contained an EGFR inhibitor
- Gemcitabine hydrochloride used as either a radiosensitizer or as maintenance therapy is allowed, provided more than 6 months have elapsed since the last day of treatment
- No prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib hydrochloride, erlotinib hydrochloride, or lapatinib)
- No concurrent immunotherapy or radiotherapy
- No other concurrent chemotherapy
- No concurrent colony-stimulating factors during the first course of study therapy
Data sourced from ClinicalTrials.gov (NCT00550836). 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.