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Erlotinib and Sunitinib in NSCLC

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ClinicalTrials.gov Identifier: NCT00581789
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : February 14, 2012
Sponsor:
Collaborators:
Pfizer
Genentech, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: erlotinib, sunitinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Erlotinib and Sunitinib in Non-small Cell Lung Cancer
Study Start Date : August 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)
Drug: erlotinib, sunitinib
erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)
Other Names:
  • Tarceva
  • OSI-774
  • Sutent
  • SU011248



Primary Outcome Measures :
  1. Safety [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581789


Locations
United States, Wisconsin
University of Wisconsin Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Pfizer
Genentech, Inc.
Investigators
Principal Investigator: Anne Traynor, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00581789     History of Changes
Other Study ID Numbers: H-2007-0063
CO05507
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

Keywords provided by University of Wisconsin, Madison:
non small cell lung cancer
sunitinib
erlotinib
phase 1

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Sunitinib
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors