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Erlotinib and Sunitinib in NSCLC

Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Cancer

Intervention: erlotinib, sunitinib (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Wisconsin, Madison

Official(s) and/or principal investigator(s):
Anne Traynor, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison

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.

Clinical Details

Official title: Phase I Study of Erlotinib and Sunitinib in Non-small Cell Lung Cancer

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety

Secondary outcome: Response rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion 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. Exclusion 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

Locations and Contacts

University of Wisconsin Carbone Comprehensive Cancer Center, Madison, Wisconsin 53792, United States
Additional Information

Starting date: August 2007
Last updated: February 10, 2012

Page last updated: August 23, 2015

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