Phase 2 Completed N=37 Treatment

Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery

Pancreatic Cancer

Source: ClinicalTrials.gov NCT00837876 ↗

Enrolled (actual)

Serious AEs

73.0%

Results posted

Sep 2012

Primary outcomePrimary: Number of Patients With Progression-free Survival — 10 participants

Summary

RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with pancreatic cancer that cannot be removed by surgery.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Progression-free Survival	4	—
SECONDARY Response Rate	0; 0; 8; 19	—
SECONDARY Number of Patients With Progression-free Survival	4	—
SECONDARY Number of Patients With Worst Grade Toxicities	1; 5; 26; 3; 1	—

Eligibility Criteria

DISEASE CHARACTERISTICS:

Microscopically confirmed diagnosis of pancreatic adenocarcinoma
Unresectable disease
No neuroendocrine tumors or cystadenocarcinoma
Measurable or evaluable disease by RECIST criteria
No known brain metastases
Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
Creatinine ≤ 1.5 times ULN
INR 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management
No arterial thrombotic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 in the past 4 weeks
No other hemorrhage/bleeding event ≥ CTCAE grade 3 in the past 4 weeks
No significant traumatic injury in the past 4 weeks
No known untreated malabsorption problem (e.g., ulcerative colitis, Crohn's disease)
No known HIV positivity or chronic hepatitis B or C
No known or suspected allergy to sorafenib tosylate or erlotinib hydrochloride
No active clinically serious infection > CTCAE grade 2
No serious non-healing wound, ulcer, or bone fracture
No evidence or history of bleeding diathesis or coagulopathy (except for cancer-related blood clots)
No dermatitis ≥ CTCAE grade 2 at baseline
No patients who currently smoke

PRIOR CONCURRENT THERAPY:

No prior treatment with antiangiogenics (e.g., bevacizumab, thalidomide, marimastat, interferon alfa, vatalanib, vandetanib, ZD6126, sorafenib, semaxanib, sunitinib, axitinib)
No more than one line of prior therapy for metastatic disease
More than 4 weeks since prior major surgery or open biopsy
No concurrent strong CYP34A inhibitors or inducers
Concurrent warfarin or heparin allowed with the approval of the principal investigator

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00837876). 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.