Erlotinib and Sunitinib in NSCLC

NCT00581789

Last updated date
Study Location
University of Wisconsin Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Non Small Cell Lung CancerSunitinib Non Small Cell Lung Cancer Patients Over 70
NCT00864721
  1. Ocala, Florida
  2. Ocoee, Florida
  3. Minneapolis, Minnesota
  4. Raleigh, North Carolina
  5. Eugene, Oregon
  6. Greenville, South Carolina
  7. Arlington, Texas
  8. Bedford, Texas
  9. Dallas, Texas
  10. Mesquite, Texas
  11. Waco, Texas
  12. Norfolk, Virginia
  13. Yakima, Washington
ALL GENDERS
70 Years+
years
MULTIPLE SITES
Non Small Cell Lung CancerErlotinib and Sunitinib in NSCLC
NCT00581789
  1. Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non Small Cell Lung CancerSalvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer
NCT01019798
  1. Taipei,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non Small Cell Lung CancerA Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer
NCT01121575
  1. Aurora, Colorado
  2. Aurora, Colorado
  3. Aurora, Colorado
  4. Aurora, Colorado
  5. Bethesda, Maryland
  6. Boston, Massachusetts
  7. Boston, Massachusetts
  8. Boston, Massachusetts
  9. Boston, Massachusetts
  10. East Melbourne, Victoria
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Erlotinib and Sunitinib in NSCLC
Official Title  ICMJE Phase I Study of Erlotinib and Sunitinib in Non-small Cell Lung Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)
Intervention: Drug: erlotinib, sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2012)
11
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2007)
12
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00581789
Other Study ID Numbers  ICMJE H-2007-0063
CO05507
H-2007-0063 ( Other Identifier: Institutional Review Board )
A534260 ( Other Identifier: UW Madison )
SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison )
NCI-2011-00549 ( Registry Identifier: NCI Trial ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • Pfizer
  • Genentech, Inc.
Investigators  ICMJE
Principal Investigator:Anne Traynor, MDUniversity of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP