Clinical Trial: Cancer, Lung Cancer, MSK

MSK 14-167 Lung Cancer

Full Name

MSK 14-167: Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis

Description

Experimental: Nintedanib + Prednisone

The initial dose of nintedanib will be 150mg two times per day orally according to study protocol. Nintedanib will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks).

Interventions:

Drug: Nintedanib

Drug: Prednisone

Experimental: Placebo + Prednisone

Placebo will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks).

Interventions:

Drug: Prednisone

Other: Placebo

Eligibility

Inclusion Criteria
  • Histologically/cytologically proven primary thoracic malignancy or lung metastases (which are not required to be biopsy-proven) treated with definitive intent at MSK
  • Prior treatment with thoracic radiotherapy completed >4 weeks and ≤ 9 months prior to enrollment
  • Radiographic evidence of radiation pneumonitis on a CT scan of the chest with or without contrast
  • Newly diagnosed clinical grade 2 or higher radiation pneumonitis according to CTCAE version 4.0 criteria
  • Age≥18 years
  • KPS > 70%
  • Reduction of any acute toxicity from radiation treatment to grade 1
  • Written informed consent signed prior to entry into the study
Exclusion Criteria
  • Current oral steroid use > 2 weeks prior to registration
  • Ongoing treatment with radiotherapy to thorax, cytotoxic or biological therapies for this malignancy
  • Persistent >grade 1 esophagitis
  • Mean esophageal radiation dose >45 Gy
  • Diagnosis of diffuse radiation pneumonitis
  • Untreated or symptomatic brain metastases or leptomeningeal disease
  • Liver metastases
  • Other active malignancies
  • Radiographic evidence of cavitary or necrotic tumor and local invasion of major blood vessels
  • Active chronic Hepatitis C and/or B infection
  • Gastrointestinal disorders that would interfere with drug absorption
  • AST, ALT>1.5x ULN and/or Bilirubin>ULN 1.5 X ULN
  • ≥ Grade 2 proteinuria, creatinine >1.5x ULN or GFR <45 ml/min
  • Other investigational therapy received within 8 weeks prior to screening visit
  • Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrollment1
  • Sexually active males not committing to birth control during the course of the study (except if their partner is not of childbearing potential)
  • Conditions that may affect the patient's ability to participate in this trial, e.g. known or suspected active alcohol or drug abuse
  • Inherited predisposition to bleeding or thrombosis, INR >2, PT and PTT >1.5x ULN
  • History of bleeding disorders or thrombotic events, e.g. hemorrhagic or thrombotic events within 12 months, clinically significant or tumor-related hemoptysis, active gastrointestinal bleeding or ulcers or major injuries or surgery
  • ANC < 1.5 K/mcL, Platelets < 100 K/mcL, Hemoglobin < 9.0 g/dl
  • Concomitant treatment with any of the following drugs: azathioprine, cyclophosphamide, cyclosporine, pirfenidone, full dose anticoagulation (vitamin K antagonists, dabigatran, heparin), fibrinolysis and high dose anti-platelet therapy (ex. Plavix 150mg)^2 Myocardial infarction or unstable angina within 6 or 1 month of starting nintedanib treatment, respectively
  • Known inherited predisposition to thrombosis
  • Patient with a history of a thrombotic event within 12 months of starting nintedanib treatment
  • Known predisposition to bleeding
  • Patients on fibrinolysis, full-dose therapeutic anticoagulation, or high dose antiplatelet therapy
  • Patients with severe hepatic impairment
  • History of a gastrointestinal perforation
Doctor(s) Running This Study

Accepting New Patients

Specialties
Radiation Oncology
Area of focus
Lung Cancer
Head and Neck Cancers
Breast Cancer
Pediatric Radiation Therapy
LVHN Affiliates
Lehigh Valley Cancer Institute
Locations

2545 Schoenersville Road
Radiation Oncology
Bethlehem, PA 18017-7384
United States

1240 S Cedar Crest Blvd, Ground Floor
Dept of Radiation Oncology
Allentown, PA 18103-6218
United States

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