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Induction Study of Cisplatin, Docetaxel, and Nintedanib Stage IB-IIIA Non-Small Cell Lung Cancer (NCLC)

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: Nintedanib (Drug); Cisplatin (Drug); Docetaxel (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
William N. William Jr., MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
William N. William Jr., MD, Phone: 713-792-6363

Summary

The goal of this clinical research study is to learn if it is safe to give nintedanib in combination with cisplatin and docetaxel before surgery to patients with NSCLC. Researchers also want to learn if the drug combination can help to control NSCLC before surgery.

Clinical Details

Official title: Phase I Study of Induction Cisplatin, Docetaxel and Nintedanib for Stage IB-IIIA Non-small Cell Lung Cancers Amenable for Surgical Resection

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Major Pathologic Response Rate

Toxicity of Nintedanib Given With Cisplatin and Docetaxel

Secondary outcome: Recurrence-Free Survival

Detailed description: Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 2 groups of up to 6 participants will be enrolled in the Run-In Phase of the study, and up to 33 participants will be enrolled in the Expansion Phase. If you are enrolled in the Run-In Phase, the dose of nintedanib you receive will depend on when you joined this study. The first group of participants will receive a dose level of nintedanib. If no intolerable side effects are seen, a second group will be enrolled at a higher dose level. If intolerable side effects are seen, a group will be enrolled at a lower dose level. If you are enrolled in the Expansion Phase, you will receive nintedanib at the highest dose that was tolerated in the Run-In Phase. All participants will receive the same dose level of cisplatin and docetaxel. Study Drug Administration: Run-In Phase: You will receive cisplatin over 2 hours and docetaxel over 1 hour by vein on Day 1 of each 21-day study cycle. You will take nintedanib by mouth every day from Day 2 of Cycle 1 through Day 7 of Cycle 3, except for the days that you receive cisplatin and docetaxel. Expansion Phase: You will take capsules of nintedanib by mouth every day for a 28 day priming cycle (Cycle 0). You will then receive cisplatin over 2 hours and docetaxel over 1 hour by vein on Day 1 of each 21-day study cycle. You will take nintedanib by mouth every day from Day 2 of Cycle 1 through Day 7 of Cycle 3, except for the days that you receive cisplatin and docetaxel. All Patients: You should take capsules of nintedanib with about a cup (8 ounces) of water. Swallow the capsules whole and do not chew them. If you take nintedanib 2 times daily, you should take the drug about 12 hours apart each time. If you miss a dose, wait and take the next scheduled dose when it is due. You will then have surgery at least 21 days after the last dose of nintedanib, unless the study doctor thinks it is not in your best interest. Study Visits: If you are in the Expansion Phase, on Day 28 of Cycle 0:

- You will have a physical exam.

- Blood (about 1 tablespoon) will be drawn for routine tests and for biomarker testing.

- You will have a CT scan to check the status of the disease.

Within 7 days before Cycles 2 and 3:

- You will have a physical exam.

- Blood (about 1 tablespoon) will be drawn for routine tests and for biomarker testing.

About 14 days after your last cycle of chemotherapy:

- You will have a physical exam.

- Blood (about 1 tablespoon) will be drawn for routine tests and for biomarker testing.

- You will have a PET/CT and CT scan to check the status of the disease.

Some blood draws and/or imaging scans may need to be performed more frequently if certain side effects (such as those affecting the liver) occur. Surgery: Between 3 and 5 weeks after you stop taking the study drugs, you will have surgery to remove the disease. You will sign a separate consent form that explains the procedure, as well as its risks and benefits. During surgery, tissue samples that are removed will be collected and stored in a research tissue bank at MD Anderson for use in future biomarker research and other research related to cancer. Length of Treatment: You may receive the study drugs for up to 3 cycles, followed by surgery. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your active participation on the study will be over after the end-of-treatment visit. End-of-Treatment Visit: Within 8 weeks after you have surgery, the following tests and procedures will be performed, you will have a physical exam and blood (about 2 teaspoons) will be drawn for biomarker testing. Long-Term Follow-Up: After the end-of-treatment visit, your medical record will be reviewed or you will be called, contacted in writing, or e-mailed to check on your health status. If you are called, these calls should last about 5 minutes. You may also be asked these questions during regularly scheduled clinic visits. The follow-up period will last for as long as the study doctor thinks the information is needed. This is an investigational study. Docetaxel and cisplatin are FDA approved and commercially available for the treatment of NSCLC. Nintedanib is commercially available and FDA approved for the treatment of idiopathic pulmonary fibrosis (a type of lung disease). Its use in this study is investigational. Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age 18 years and older 2. Histologically or cytologically confirmed non-small cell lung cancer. Patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatment on study. Neuroendocrine carcinomas are not eligible. Carcinomas with neuroendocrine differentiation are eligible. 3. Stage IB (with a primary tumor >/= 4cm), IIA, IIB, or IIIA (according to AJCC 7th edition). Patients with stage IIIA must not have more than one mediastinal lymph node station involved by tumor. 4. All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude N3 disease. 5. The patient must be a suitable candidate for surgery, in the opinion of the treating physician. 6. ECOG performance status score 0-1 7. Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation Exclusion Criteria: 1. Prior systemic therapy or radiation therapy for treatment of the current lung cancer 2. Known hypersensitivity to the trial drugs or to their excipients 3. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels 4. Radiographic evidence of cavitary or necrotic tumor 5. Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing 6. History of clinically significant haemorrhagic or thromboembolic event in the past 6 months 7. Known inherited predisposition to bleeding or thrombosis 8. Significant cardiovascular diseases (i. e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion) 9. Creatinine > 1. 5 institutional upper limit of normal. Patients with creatinine > 1. 5 the institutional upper limit of normal who have creatinine clearance >/= 60 cc/min (calculated using the Cockcroft and Gault equation) are eligible 10. Hepatic function: total bilirubin > institutional upper limit of normal or AST > 1. 5 x institutional upper limit of normal 11. Coagulation parameters: International normalised ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN 12. Absolute neutrophil count ( ANC) < 1500/ml, and/or platelets < 100000/ml 13. Prior malignancy requiring systemic therapy or radiation therapy within 1 year of randomization 14. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy 15. Active or chronic hepatitis C and/or B infection 16. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug 17. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study 18. Patients who are sexually active, with preserved reproductive capacity, and unwilling to use a medically acceptable method of contraception (e. g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy 19. Pregnancy or breast feeding. 20. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.

Locations and Contacts

William N. William Jr., MD, Phone: 713-792-6363

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: April 2015
Last updated: August 5, 2015

Page last updated: August 23, 2015

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