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Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation

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ClinicalTrials.gov Identifier: NCT01836341
Recruitment Status : Withdrawn
First Posted : April 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Collaborators:
Boehringer Ingelheim
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE April 17, 2013
First Posted Date  ICMJE April 19, 2013
Last Update Posted Date December 19, 2013
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
maximum tolerated dose [ Time Frame: 1 year ]
This will be defined as the dose at which fewer than 1:6 patients experiences a dose-limiting toxicity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • local control rate [ Time Frame: at 1 year and at 2 years ]
    will be determined as the proportion of patients who start the concurrent phase who are alive and free of local failure.
  • tolerability of adjuvant afatinib [ Time Frame: at 3 months ]
    Tolerability will be defined by in terms of dose reductions, delays and discontinuations of patients who have not had disease progression or death.
  • median progression free survival [ Time Frame: 2 years ]
    PFS is defined as the duration of time from start of treatment to time of progression of disease or death, whichever occurs first.
  • median overall survival [ Time Frame: 2 years ]
    will be calculated using Kaplan-Meier estimates among all patients enrolled.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
Official Title  ICMJE A Dose-Finding Study Of Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
Brief Summary The purpose of this Phase I study is to test the safety of combining afatinib with standard chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This study will then test the safety of afatinib at different dose levels when combined with the chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given during radiation treatment and the drug afatinib will be continued after chemotherapy and radiation.
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: Afatinib
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Drug: Pemetrexed
  • Radiation: Radiation therapy
Study Arms  ICMJE Experimental: Afatinib w Cisplatin Pemetrexed Chemoradiation

induction afatinib 40mg daily x 28days Cisplatin or Carboplatin (can be used if patient is not eligible for cisplatin) + Pemetrexed + 50Gy to pretreatment field boost to 60Gy to residual tumor + afatinib dose escalation*

*afatinib dose levels: 20mg daily, 30mg daily & 40mg daily (3+3 design) Then adjuvant afatinib x 2 years

Interventions:
  • Drug: Afatinib
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Drug: Pemetrexed
  • Radiation: Radiation therapy
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 18, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2013)
24
Estimated Study Completion Date  ICMJE April 2015
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unresectable or inoperable, stage III or locoregional recurrence without evidence of distant, metastatic disease
  • Pathologic confirmation of NSCLC at MSKCC
  • Documentation of a sensitizing EGFR mutation
  • Age ≥ 18 years
  • No contraindication to definitive thoracic radiation therapy with concurrent chemotherapy

Adequate organ function as defined by:

  • Calculated creatinine clearance≥ 45 mL/min (by Cockcroft-Gault)
  • Total bilirubin less than 1.5 x ULN (unless known Gilbert's disease) and AST/ALT less than 3 x ULN
  • Absolute neutrophil count greater than 1500/mm3
  • Platelet count greater than 100,000/mm3
  • Women of childbearing age must have a negative blood pregnancy test
  • Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months there after

Exclusion Criteria:

  • Prior chemotherapy or radiation therapy for this lung cancer (history of prior lung cancer that has been treated and deeded inactive by the clinician is acceptable)
  • Ineligible for cisplatin or carboplatin per medical oncologist
  • Ineligible for pemetrexed per medical oncologist
  • Greater than minimal, exudative, or malignant pleural effusion
  • Calculated creatinine clearance by Cockcroft & Gault method ≤45 ml/min
  • Unstable congestive heart failure
  • Ejection fraction <50% as assessed by MUGA or echocardiogram
  • Interstitial lung disease
  • Patient requiring on-going treatment with a potent inhibitor (cyclosporin, erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital with quinidine, ritonavir, valspodar, verapamil) or inducer of P-gp (St. John's wort or rifampin)
  • Women who are breastfeeding
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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01836341
Other Study ID Numbers  ICMJE 12-279
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • Boehringer Ingelheim
  • National Comprehensive Cancer Network
Investigators  ICMJE
Principal Investigator: Jamie E. Chaft, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2013

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