Randomized, Double-Blind Trial of Erlotinib/Pazopanib or Erlotinib/Placebo in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer

NCT01027598 | Completed Phase 2 Results

• 1 other identifier: SCRI LUN 200
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 8

Brief Summary

This randomized, placebo-controlled, Phase II trial will compare the combination of erlotinib with pazopanib (providing concurrent EGFR and VEGFR inhibition) with erlotinib alone in the second- or third-line treatment of patients with advanced NSCLC. This study will be conducted though the Sarah Cannon Research Consortium, a community-based clinical trial network.

Conditions

Non Small Cell Lung Cancer

Keywords

Lung Cancer; Previously Treated Advanced Non Small Cell Lung Cancer; Erlotinib; Pazopanib

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  The length of time, in months, that patients were alive from first date of protocol treatment until worsening of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  14 months

Secondary Outcomes (2)

• Overall Survival

  18 months

• Objective Response Rate (ORR)

  18 Months

Study Arms (2)

Erlotinib + Pazopanib

EXPERIMENTAL

Erlotinib: 150 mg orally daily Pazopanib: 600 mg orally daily

Drug: Pazopanib; Drug: Erlotinib

Erlotinib + Placebo

PLACEBO COMPARATOR

Erlotinib: 150 mg orally daily Placebo: orally daily

Drug: Erlotinib

Interventions

Pazopanib DRUG

Pazopanib: 600 mg orally daily

Also known as: Votrient

Erlotinib + Pazopanib

Erlotinib DRUG

Erlotinib: 150 mg orally daily

Also known as: Tarceva

Erlotinib + Pazopanib; Erlotinib + Placebo

Eligibility Criteria

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

You may qualify if:

• Pathologic confirmation of stage IIIB/IV NSCLC (squamous carcinoma, adenocarcinoma, or large cell carcinoma) per the American Joint Committee on Cancer Cancer Staging Manual, 6th edition. Patients with mixed tumors with small- cell elements are ineligible.
• At least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques, or as \>10 mm with spiral computerized tomography scan according to the Response Evaluation Criteria in Solid Tumors version 1.1 (Eisenhauer et al. 2009)
• Failure of at least 1, and no more than 2, prior chemotherapy regimens for advanced disease (either due to progressive disease or toxicity).
• Recovery from any toxic effects of prior therapy to ≤ grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
• Completion of radiation therapy at least 28 days prior to the start of study treatment (not including palliative local radiation). Previously irradiated lesions in the advanced setting cannot be included as target lesions unless clear tumor progression has been observed since the end of radiation.
• ECOG Performance Status of 0-2.
• Adequate hematologic, hepatic and renal function.
• A female is eligible to enter and participate in this study if she is of:
• non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation, is post-menopausal
• childbearing potential, including any female who has had a negative serum pregnancy test within 1 week prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception.
• Patients entering the study must be willing to provide a serum sample at baseline and at off-study for disease progression for correlative serum proteomic testing.
• Willingness to provide a plasma sample at baseline, and at off-study for disease progression for correlative testing of circulating plasma biomarkers.
• Patients entering this study must be willing to provide tissue from a previous tumor biopsy (if available) for correlative tissue testing.
• Patients must be able to understand the nature of this study, give written informed consent, and comply with study requirements.

You may not qualify if:

• Past or current history of neoplasm (other than the entry diagnosis), with the exception of treated non-melanoma skin cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy alone, and a disease-free survival ≥3 years.
• Prior treatment with EGFR tyrosine kinase inhibitors or vascular endothelial factor receptor tyrosine kinase inhibitors for NSCLC. \[Note: prior bevacizumab (Avastin®) use is permitted\].
• Prior use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting
• Myocardial infarction
• Unstable angina
• Coronary artery bypass graft surgery
• Symptomatic peripheral vascular disease
• Class III or IV congestive heart failure, as defined by New York Heart Association classification
• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 1 week prior to first dose of study drug. Screening with CNS imaging (CT or magnetic resonance imaging) is required only if clinically indicated or if the subject has a history of CNS metastases.
• Women who are pregnant or lactating. All females of childbearing potential must have negative serum or urine pregnancy tests within 7 days prior to study treatment.
• Poorly controlled hypertension \[defined as systolic blood pressure of ≥150 mmHg or diastolic blood pressure of ≥90mmHg\].
• Presence of uncontrolled infection.
• Prolongation of heart rate-corrected QT interval (QTc) ≥480 msec (using Bazett's formula).

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• GlaxoSmithKline: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (8)

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Suburban Hem Onc

Lawrenceville, Georgia, 30045, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

South Carolina Oncology Associates, PA

Columbia, South Carolina, 29210, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Family Cancer Center

Collerville, Tennessee, 38119, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

pazopanib; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John D. Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• David R Spigel, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 8, 2009
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 29, 2016
• Results First Posted: January 29, 2016

Record last verified: 2015-12

Locations

US (8)