Erlotinib and Sunitinib in NSCLC

NCT00581789 | Completed Phase 1 DMC

• 5 other identifiers: H-2007-0063CO05507A534260SMPH\MEDICINE\HEM-ONCNCI-2011-00549
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

• To determine the safety and maximally tolerated dose of sunitinib plus erlotinib in patients with non-small cell lung cancer (NSCLC).
• To determine response to sunitinib plus erlotinib in patients with non-small cell lung cancer.

Conditions

Non Small Cell Lung Cancer

Keywords

non small cell lung cancer; sunitinib; erlotinib; phase 1

Outcome Measures

Primary Outcomes (1)

• Safety

  12 months

Secondary Outcomes (1)

• Response rate

  12 months

Study Arms (1)

1

EXPERIMENTAL

Erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)

Drug: erlotinib, sunitinib

Interventions

erlotinib, sunitinib DRUG

erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)

Also known as: Tarceva, OSI-774, Sutent, SU011248

1

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically proven stage IIIB (with pleural effusion or pericardial effusion) or IV (either primary or recurrent) NSCLC (except squamous cell histology).
• Measurable disease per RECIST
• Life expectancy of at least 12 weeks.
• Adequate bone marrow, hepatic and renal function
• ECOG performance status 0, 1 or 2.
• One and only one prior treatment with a chemotherapy regimen, including a platinum based regimen for advanced disease (Stage IIIB with malignant effusion or Stage IV).
• Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
• Female patients must be surgically sterile, postmenopausal or agree to use effective contraception during the period of therapy. Male patients must be surgically sterile or agree to use effective contraception during the period of therapy.

You may not qualify if:

• Squamous cell histology.
• History of untreated brain metastases
• Prior treatment with \>1 systemic chemotherapy-based regimens for advanced disease (Stage IIIB with malignant effusion or Stage IV).
• Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors (including but not limited to bevacizumab, sunitinib, erlotinib, gefitinib, or thalidomide).
• Prior chemotherapy, radiation therapy, surgery, or investigational agent within 4 weeks prior to study entry, except palliative radiation therapy to a non-target lesions (must have been completed 2 weeks prior to study enrollment).
• Eligibility of patients receiving any medications or substances known to induce or inhibit CYP3A4 and /or with the potential to affect the activity or pharmacokinetics of sunitinib or erlotinib will be determined following review of their case by the Principal Investigator.
• NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy.
• Ongoing treatment with warfarin
• Prior treatment with high-dose chemotherapy requiring stem cell rescue.
• Prior irradiation to \>25% of the bone marrow (whole pelvis = 25%).
• Diagnosis within prior 3 years of second malignancy, except basal cell carcinoma, squamous cell skin carcinoma or in situ carcinoma that has been completely treated without evidence of recurrent disease for 12 months.
• Current treatment on another therapeutic clinical trial or receipt of another investigative agent within 4 weeks of study entry.
• Any of the following within 12 months prior to starting study treatment: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
• Hypertension (\>150/100mmHg) that cannot be controlled with standard antihypertensive agents.
• Ongoing cardiac dysrhythmias of grade \>2, ≥ grade 3 atrial fibrillation, or QTc interval of \>450 msec for males and \>470 msec for females.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Pfizer: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

University of Wisconsin Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Sunitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung 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; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Indoles

Study Officials

• Anne Traynor, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2011
• Last Updated: November 19, 2019

Record last verified: 2012-02

Locations

US (1)