A Study of Dasatinib With Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer (NSCLC)

NCT00787852 | Terminated Phase 1 Results

• 1 other identifier: BrUOG-NSCL-216
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if a maximum dose of 100 mg of dasatinib with concurrent chemoradiation can be tolerated in patients with chemotherapy naive stage III NSCLC in separate cohorts of locally advanced and potentially resectable disease.

Conditions

Non-Small Cell Lung Cancer

Keywords

dasatinib; radiation; paclitaxel; carboplatin; NSCLC; safety addition of dasatinib to chemo RT stage III NSCLC

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Came Off Study for Toxicity Using CTC Version 3.0

  6 patients came off study for toxicity

  within 28 days after the last radiation treatment

Secondary Outcomes (1)

• Complete and Partial Response by CT Scan or MRI

  within 30 days of last treatment

Study Arms (2)

Group 1: Radiation, Paclitaxel, Carbo, Dasatinib days 1-47

EXPERIMENTAL

Locally Advanced Stage III NSCLC DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years\*

Drug: Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47

Group 2: Radiation, Paclitaxel, carbo, Dasatinib days 1-38

EXPERIMENTAL

Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years\*

Drug: Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38

Interventions

Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47 DRUG

Locally Advanced Stage III NSCLC DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years\*

Also known as: Group 1: Locally Advanced Stage III NSCLC

Group 1: Radiation, Paclitaxel, Carbo, Dasatinib days 1-47

Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38 DRUG

Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years\*

Also known as: Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC

Group 2: Radiation, Paclitaxel, carbo, Dasatinib days 1-38

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, \[according to AJCC Staging, 6th edition; see Appendix G\] within 4 weeks of registration.
• No prior chemotherapy or radiation for lung cancer. No prior radiation for any malignancy within the radiation field.
• Patients may be potentially resectable or unresectable.
• Stage III A or B disease, including no distant metastases- based on following diagnostic workup:
• History/physical examination prior to registration.
• CT Scan of the chest or Pet Scan within 28 days of study entry.
• CT Scan of abdomen or MRI of abdomen or Pet Scan within 28 days of study entry.
• An MRI of the brain or Head CT Scan with contrast within 28 days of study entry.
• Total body PET scan within 6 weeks of study entry is highly recommended and required for operable patients. If a PET scan is performed then a bone scan is not required.
• A bone scan should be performed within 6 weeks of study entry. A bone scan is not needed if a PET scan is performed.
• Mediastinoscopies are highly recommended. Mediastinoscopy is required for all patients not undergoing PET scans and for those who are operable.
• Patients must have measurable or evaluable disease.
• Patients with post-obstructive pneumonia are eligible.
• Patients must be at least 3 weeks from prior thoracotomy (if performed)
• ECOG Performance Status 0-1. Age \> 18.

You may not qualify if:

• Supraclavicular disease
• Pleural or pericardial effusion of any grade
• No prior malignancy \[other than the one treated in this study\] which required radiotherapy or systemic treatment within the past 3 years
• Severe, active co-morbidity, defined as follows:
• Uncontrolled angina, congestive heart failure or MI within (6 months)
• Diagnosed congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
• Prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec)
• Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
• Protocol-specific requirements may also exclude immuno-compromised patients
• History of significant bleeding disorder unrelated to cancer, including:
• Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).
• Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).

Sponsors & Collaborators

• Brown University: lead
• Rhode Island Hospital: collaborator
• Memorial Hospital of Rhode Island: collaborator

Study Sites (1)

Lifespan Hospitals

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Howard Safran, MD
• Organization: BrUOG

kayla_rosati@brown.edu

4018633000

Study Officials

• Howard Safran, md

  Brown University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 10, 2008
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 30, 2014
• Results First Posted: September 25, 2013

Record last verified: 2014-07

Locations

US (1)