Sorafenib and High-Dose Carboplatin, Paclitaxel, and External-Beam Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 10, 2019 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- University of Texas Southwestern Medical Center
- Interventions being studied
- Drug: carboplatin; Drug: paclitaxel; Drug: sorafenib tosylate; Radiation: radiation therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- DISEASE CHARACTERISTICS:
- 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
- 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: Inclusion criteria:
- 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
- Weight loss ≤ 10% over the past 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Women of childbearing potential and male participants who are unwilling or unable to use an acceptable method of contraception throughout the study and for 4 weeks after completion of treatment or those who are using a prohibited contraceptive method
- INR \< 1.5 or a PT/PTT within normal limits
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arlington Cancer Center - ArlingtonArlington, Texas
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 10, 2019. Always confirm current availability with the study team.