Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
M.D. Anderson Cancer Center
With
PRIMARY OBJECTIVES: I. To determine safety of nintedanib incorporated to chemotherapy in the induction setting. II. To determine the major pathologic response rate in patients treated with induction nintedanib and chemotherapy. SECONDARY OBJECTIVES: I. Response rates to induction treatment (by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1). II. Response rates to priming therapy with nintedanib single agent (by computed tomography \[CT\] assessment using RECIST version 1.1). III. Recurrence-free survival. IV. Overall survival. V. Correlations between major pathologic response with recurrence-free and overall survival. VI. Toxicity (assessed by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4). VII. Peri-operative morbidity and mortality. VIII. Complete resection (R0) rate. IX. Correlations of response assessed by imaging studies with outcomes (both pathologic response to treatment and long-term recurrence-free survival). X. Correlations of blood- and tissue-based biomarkers with efficacy and toxicity. OUTLINE: This is a dose-escalation study of nintedanib. RUN-IN PHASE: Patients receive induction therapy comprising cisplatin intravenously (IV) over 2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib orally (PO) twice daily (BID) from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues even if patients experience disease progression, unless treatment is judged to be not in the best interest of the patient by the treating physician. After completion of study treatment, patients are followed up within 8 weeks and then periodically thereafter.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
