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Erlotinib and Sunitinib in NSCLC
This study is currently recruiting participants.
Verified by University of Wisconsin, Madison, June 2008
First Received: December 19, 2007   Last Updated: June 2, 2008   History of Changes
Sponsors and Collaborators: University of Wisconsin, Madison
Pfizer
Genentech
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00581789
  Purpose
  • 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 Intervention Phase
Non Small Cell Lung Cancer
Drug: erlotinib, sunitinb
Phase I

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib hydrochloride Erlotinib Sunitinib malate Sunitinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Phase I Study of Erlotinib and Sunitinib in Non-Small Cell Lung Cancer

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)
Drug: erlotinib, sunitinb
erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581789

Contacts
Contact: Cancer Connect 800-622-8922 uwccc@uwccc.wisc.edu

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

No publications provided

Responsible Party: University of Wisconsin ( Anne Traynor, MD )
Study ID Numbers: H-2007-0063, CO05507
Study First Received: December 19, 2007
Last Updated: June 2, 2008
ClinicalTrials.gov Identifier: NCT00581789     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Respiratory Tract Diseases
Sunitinib
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sunitinib
Therapeutic Uses
Lung Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009