A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors

NCT00947167 | Terminated Phase 2 Results DMC

• 4 other identifiers: NET0008SU-03272009-203916186END0008
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Neuroendocrine Tumors; Carcinoid Tumors; Adrenal Gland Tumors; Neuroblastoma; Pancreatic Neuroendocrine Tumors; Multiple Endocrine Neoplasia

Outcome Measures

Primary Outcomes (1)

• Response Rate (RR) for All Patients Treated With This Strategy (Simon Design)

  RECIST v1.1 used

  CT scans are done every 4 cycles (every 12 wks)

Secondary Outcomes (1)

• Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly

  AEs are assessed every cycle (every 3 wks)

Study Arms (1)

Pertuzumab and Erlotinib

EXPERIMENTAL

Drug: pertuzumab; Drug: erlotinib

Interventions

pertuzumab DRUG

840 mg, 420 mg, iv

Also known as: 2C4, Omnitarg, Genentech

Pertuzumab and Erlotinib

erlotinib DRUG

150 mg, PO

Also known as: Tarceva, Erlotinib hydrochloride

Pertuzumab and Erlotinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be treated at Stanford University Medical Center for the entire length of study participation.
• 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.
• 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.
• Prior chemotherapy will be permitted.
• Prior or concurrent somatostatin analogue use will be permitted.
• 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.
• Patients must have ECOG performance status of 0-2.
• Patients must be \>= 18 years of age.
• 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.

You may not qualify if:

• Prior full field radiotherapy \<= 4 weeks or limited field radiotherapy \<= 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
• Prior biologic or immunotherapy \<= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
• If history of other primary cancer, subject will be eligible only if she or he has:
• Curatively resected non-melanomatous skin cancer
• Curatively treated cervical carcinoma in situ
• Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
• Concurrent use of other investigational agents and patients who have received investigational drugs \<= 4 weeks prior to enrollment.
• Subjects known to have chronic or active hepatitis B or C infection with impaired hepatic function (ineligible if AST and ALT \> 3.0 x ULN).
• History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
• Male subject who is not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of second-line treatment
• Female subject (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) who is not willing to use an oral, patch or implanted contraceptive, double-barrier birth control, or an IUD during the course of the study and for 6 months following the last dose of second-line treatment
• Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization
• Pleural effusion or ascites that causes respiratory compromise (\>= CTCAE grade 2 dyspnea)
• Any of the following concurrent severe and/or uncontrolled medical conditions within 24 weeks of enrollment which could compromise participation in the study:
• Unstable angina pectoris

Sponsors & Collaborators

• Pamela L. Kunz: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoid Tumor; Adrenal Gland Neoplasms; Neuroblastoma; Multiple Endocrine Neoplasia

Interventions

pertuzumab; (18F)GTP1; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Gland Diseases; Endocrine System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination due to toxicity, thus small number of patients analyzed and limited statistical power.

Results Point of Contact

• Title: Pamela L. Kunz, MD, Leader GI Oncology Research Group
• Organization: Stanford University School of Medicine

pkunz@stanford.edu

650-725-8738

Study Officials

• Pamela Kunz

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 27, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 3, 2017
• Results First Posted: March 3, 2017

Record last verified: 2017-01

Locations

US (1)