Erlotinib and Sunitinib in NSCLC

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiederlotinib, sunitinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 19, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Wisconsin, Madison

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: University of Wisconsin, Madison
Interventions being studied: Drug: erlotinib, sunitinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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.

Reasons someone may not be able to joinExclusion criteria

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.
Evidence of hemoptysis \<4 weeks of starting study treatment.
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality
HIV-positive patients
Women who are pregnant or breast feeding

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Wisconsin Carbone Comprehensive Cancer CenterMadison, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 19, 2019. Always confirm current availability with the study team.

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