Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer

NCT00417248 | Terminated Phase 1 Results DMC

• 1 other identifier: HOG LUN06-107
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 8

Brief Summary

Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Disease Progression (TTP)

  18 months

Secondary Outcomes (1)

• Overall Survival

  18 months

Study Arms (1)

Investigational Treatment

EXPERIMENTAL

Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer

Drug: Cisplatin; Drug: Etoposide; Procedure: Radiotherapy; Drug: Sorafenib

Interventions

Cisplatin DRUG

Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle

Investigational Treatment

Etoposide DRUG

Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle

Investigational Treatment

Radiotherapy PROCEDURE

Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)

Investigational Treatment

Sorafenib DRUG

Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months

Investigational Treatment

Eligibility Criteria

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

You may qualify if:

• Histological or cytological proof of non-small cell lung cancer (NSCLC).
• Measurable or non-measurable disease per RECIST.
• Unresectable Stage IIIA or IIIB disease as evaluated by imaging.
• Must be age ≥ 18 years at the time of consent.
• Written informed consent and HIPAA authorization for release of personal health information.
• Females of childbearing potential and males must be willing to use an effective method of contraception.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for initial therapy.

You may not qualify if:

• No prior chemotherapy or radiotherapy for lung cancer.
• No positive supraclavicular or scalene lymph nodes extending up into the cervical region.
• No superior sulcus (pancoast tumors).
• No malignant pleural effusions. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap.
• No clinically significant or malignant pericardial effusions.
• No CNS metastases.
• No unintended weight loss (\> 5% body weight) in the preceding 90 days prior to registration for initial therapy.
• No treatment with any investigational agent within 30 days prior to being registered for initial therapy.
• No prior therapy with a Ras pathway inhibitor or anti-angiogenic agent.
• No other active cancers.
• Females must not be breastfeeding.
• No active clinically serious infections as judged by the treating investigator (\> CTC v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• No major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for initial therapy.
• No anticipation of need for major surgical procedure during the course of the study.
• No minor surgical procedures such as fine needle aspirations or cone biopsies within 7 days prior to registration for initial therapy.

Sponsors & Collaborators

• Nasser Hanna, M.D.: lead
• Bayer: collaborator
• Amgen: collaborator
• Walther Cancer Institute: collaborator

Study Sites (8)

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Center for Cancer Care at Goshen Health System

Goshen, Indiana, 46527, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Oncology Partners Network

Cincinnati, Ohio, 45247, United States

Location

Related Links

• Hoosier Cancer Research Network Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Etoposide; Radiotherapy; Sorafenib

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Clinical Data Coordinator
• Organization: Hoosier Cancer Research Network, Inc.

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• Nasser Hanna, M.D.

  Hoosier Oncology Group, LLC

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: December 28, 2006
• First Posted: December 29, 2006
• Study Start: June 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 25, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (8)