Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-… (NCT00094861) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
100 participantsStarted 2005-01
Plain-language summary
The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a histologically or cytologically proven diagnosis of NSCLC
* Unresectable (locally advanced) stage IIIa or IIIb disease
* Initial radiotherapy field of treatment to encompass greater than or equal to 30% of the esophagus
* Life expectancy greater than or equal to 6 months
* Estimated weight loss less than or equal to 10% in the 3 months before study randomization
* Measurable disease
* 18 years of age or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
* Hemoglobin (hgb) greater than or equal to 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization
* Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L without growth factor use in the 2 weeks before study randomization
* Platelet count greater than or equal to 100 x 10\^9/L
* Serum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN)
* Serum creatinine less than or equal to 2.0 mg/dL (Note: Patients with a serum creatinine greater than or equal to 1.4 and less than or equal to 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance greater than or equal to 50 mL/min)
* Females of childbearing potential: negative serum or urine pregnancy test
* Patient must give written informed consent before participating in any study-specific procedure, randomization, or receiving investigational product.
* Patients with reproductive capability must agree to practice adequat…
What they're measuring
1
Number of Participants With Grade 2 or Higher Dysphagia