Sorafenib and High-Dose Carboplatin, Paclitaxel, and External-Beam Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

NCT00547443 | Withdrawn Phase 1 DMC FDA Drug

• 4 other identifiers: SCCC-03507SCCC-052007-068BAYER-SCCC-052007-068CDR0000571535
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving sorafenib together with high-dose chemotherapy and external-beam radiation therapy may kill more tumor cells. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of sorafenib when given together with high-dose carboplatin, paclitaxel, and external-beam radiation therapy in treating patients with stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; recurrent non-small cell lung cancer; adenocarcinoma of the lung; squamous cell lung cancer; large cell lung cancer; bronchoalveolar cell lung cancer; adenosquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Median survival

  To determine the median survival from randomization for patients receiving carboplatin / paclitaxel with high dose radiation therapy or same regimen with Sorafenib.

  Mean 24-Months

Secondary Outcomes (1)

• Progression-free survival

  Mean 24-Months

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive chemoradiotherapy comprising paclitaxel, carboplatin, and high-dose external beam radiotherapy (HDRT) as in phase I. Patients also receive consolidation therapy comprising paclitaxel and carboplatin as in phase I.

Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy

Arm II

EXPERIMENTAL

Patients receive chemoradiotherapy comprising paclitaxel, carboplatin, and HDRT as in phase I. Patients also receive consolidation therapy comprising paclitaxel, carboplatin, and sorafenib tosylate at the MTD as in phase I, as well as maintenance therapy comprising sorafenib tosylate at the MTD as in phase I.

Drug: carboplatin; Drug: paclitaxel; Drug: sorafenib tosylate; Radiation: radiation therapy

Interventions

carboplatin DRUG

Given IV

Arm I; Arm II

paclitaxel DRUG

Given IV

Arm I; Arm II

sorafenib tosylate DRUG

Given orally

Arm II

radiation therapy RADIATION

Given 5 days a week for 7.5 weeks

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented non-small cell lung cancer (NSCLC)
• Any of the following subtypes allowed:
• Adenocarcinoma (including bronchoalveolar cell)
• Squamous cell carcinoma
• Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
• Poorly differentiated (not otherwise specified) NSCLC
• No metastasis (patients must be M0)
• Stage IIIA (T1 or T2 with N2 or T3N1-2) or stage IIIB (T4 with any N or any T with N2 or N3) disease
• Measurable disease
• Tumors adjacent to a vertebral body are allowed as long as all gross disease can be encompassed in the radiation boost field
• The boost volume must be limited to \< 50% of the ipsilateral lung volume
• Pleural effusion that is a transudate, cytologically negative, and nonbloody allowed if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy
• Pleural effusions seen on the chest CT but too small to tap allowed

You may not qualify if:

• Totally resected tumors
• Exudative, bloody, or cytologically malignant effusions
• Known brain metastasis
• Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis
• PATIENT CHARACTERISTICS:
• Zubrod performance status 0-1
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL (prior to transfusions)
• Total bilirubin ≤ 1.5 mg/dL
• AST or ALT ≤ 3 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Glucose ≤ 2 times ULN
• Creatinine ≤ 2.0 mg/dL
• FEV\_1 ≥ 1,200 mL

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Arlington Cancer Center - Arlington

Arlington, Texas, 76012-2510, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Carboplatin; Paclitaxel; Sorafenib; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Hak Choy, MD

  Simmons Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

US (2)