A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors
This study has been terminated.
(Extreme toxicity of Pertuzumab and Erlotinib combination)
Information provided by (Responsible Party):
Pamela L. Kunz, Stanford University
First received: July 23, 2009
Last updated: November 9, 2011
Last verified: November 2011
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).
Adrenal Gland Tumors
Pancreatic Neuroendocrine Tumors
Multiple Endocrine Neoplasia
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors
Primary Outcome Measures:
- Response rate (RR) for all patients treated with this strategy (Simon design) [ Time Frame: CT scans are done every 4 cycles (every 12 wks) ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) after erlotinib in stable patients if Simon design ends early with few progressions. [ Time Frame: CT scans are done every 4 cycles (every 12 wks) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PFS for all patients treated with this strategy [ Time Frame: CT scans are done every 4 cycles (every 12 wk) ] [ Designated as safety issue: No ]
- Toxicities assessed by CTCAE grading criteria and assigned attributions accordingly [ Time Frame: AEs are assessed every cycle (every 3 wks) ] [ Designated as safety issue: Yes ]
- RR for patients treated with combination of pertuzumab and erlotinib [ Time Frame: CT scans are done every 4 cycles (every 12 wks) ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2010 (Final data collection date for primary outcome measure)
840 mg, 420 mg, iv
150 mg, PO
- Erlotinib hydrochloride
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Albumin >= 1.5
- LVEF by TTE or MUGA >= 50%
- Life expectancy >= 12 weeks
- Ability to give written informed consent according to local guidelines
- 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.
General Medical Exclusions
- 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
- Symptomatic congestive heart failure
- Myocardial infarction <= 6 months prior to registration and/or randomization
- Serious uncontrolled cardiac arrhythmia
- Uncontrolled diabetes
- Active or uncontrolled infection
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Chronic renal disease
- Patients unwilling to or unable to comply with the protocol
- Life expectancy of less than 12 weeks
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored cancer study
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947167
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
Pamela L. Kunz
No publications provided
||Pamela L. Kunz, Assistant Professor, Stanford University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 23, 2009
||November 9, 2011
||United States: Food and Drug Administration
United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Adenoma, Islet Cell
Neoplasms by Site
Adrenal Gland Diseases
Endocrine System Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Digestive System Neoplasms
Digestive System Diseases