Erlotinib and Sunitinib in NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581789
• Other study ID #: H-2007-0063
• Secondary ID: CO05507H-2007-00
• Status: Completed
• Phase: Phase 1
• Start date: August 2007
• Est. completion date: August 2011

Study information

• Verified date: February 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• erlotinib, sunitinib
erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Genentech, Inc., Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		12 months
Secondary	Response rate		12 months

External Links

•   University of Wisconsin Carbone Cancer Center