Status:
WITHDRAWN
Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Boehringer Ingelheim
National Comprehensive Cancer Network
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01836341
Start Date
April 1 2013
End Date
April 1 2015
Last Update
December 19 2013
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