A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors
To determine objective response rates (RR) by RECIST guideline version 1.1 for all patients treated with this strategy consisting of initial therapy with pertuzumab as a single agent and then addition of erlotinib for those who have stable disease or progressive disease at three months (Simon design).
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : erlotinib
- drug : pertuzumab
Phase: Phase 2
Ages Eligible For Study:
Subjects must be treated at Stanford University Medical Center for the entire length of study participation. 1. Patients must have histologically or cytologically confirmed well-differentiated neuroendocrine tumor. Patients must be deemed unresectable due to involvement of critical vasculature or adjacent organ invasion or have metastatic disease. 2. Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases. 3. Prior chemotherapy will be permitted. 4. Prior or concurrent somatostatin analogue use will be permitted. 5. Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria (v1.1) within 4 weeks prior to entry of study. 6. Patients must have ECOG performance status of 0-2. 7. Patients must be >= 18 years of age. 8. Laboratory values <= 2 weeks prior to randomization: - Absolute Neutrophil Count (ANC) >= 1.5 x 109/L (>= 1500/mm3) - Platelets (PLT) >= 50 x 109/L (>= 100,000/mm3) (or >= 25 x 109/L (>= 100,000/mm3) if thrombocytopenia is secondary to a non-myelosuppressive cause such as splenic sequestration). - Hemoglobin (Hgb) >= 9 g/dL - Serum creatinine <= 1.5 x ULN - Serum bilirubin <= 1.5 x ULN (<= 3.0 x ULN if liver metastases present) - Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) <= 3.0 x ULN (<= 5.0 x ULN if liver metastases present). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests. - Albumin >= 1.5 9. LVEF by TTE or MUGA >= 50% 10. Life expectancy >= 12 weeks 11. Ability to give written informed consent according to local guidelines