Sorafenib and High-Dose Carboplatin, Paclitaxel, and External-Beam Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT00547443
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 0
- Starts
- 2007-07-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2019-01-10
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
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:
- 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
- Exclusion criteria:
- Known allergy to murine proteins or Cremophor EL
- Active pulmonary infection not responsive to conventional antibiotics
- History of severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations over the past year
Where it is running
- Arlington Cancer Center - Arlington — Arlington, Texas, United States
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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