Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

Stopped early · Phase 3

Conditions studied: Lung Cancer

In brief

This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.

Key facts

Study ID

NCT00004859

Run by

National Cancer Institute (NCI)

People needed

589

Starts

2000-01-01

Expected to finish

2010-03-01

Last updated by the study team

2014-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma
• Squamous cell
• Adenocarcinoma
• Large cell undifferentiated
• Bronchoalveolar
• Non-small cell carcinoma not otherwise stated
• Unresectable stage IIIA
• Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule out resectability
• OR
• Stage IIIB disease without significant pleural effusion
• Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative
• Metastases to contralateral, mediastinal, or supraclavicular nodes allowed
• Bidimensionally measurable or evaluable disease
• 18 and over
• ECOG performance status 0-1
• Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to registration:
• Platelet count at least 100,000/mm\^3
• White Blood Cell (WBC) count at least 4,000/mm\^3 OR absolute neutrophil count at least 2,000/mm\^3
• Bilirubin normal
• Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper limit of normal
• Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
• Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy
• Concurrent filgrastim (G-CSF) allowed for persistent neutropenia

You may not qualify if…

• Positive pregnancy test,pregnant or nursing
• Uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year
• Serious cardiac arrhythmias requiring medication
• Prior radiotherapy to only area of measurable or active tumor
• Less than 5 years since prior chemotherapy
• Other active malignancies
• Serious uncontrolled active infection
• Evidence of greater than grade 1 neuropathy by history or physical examination
• History of seizure disorders
• Contraindication to daily low-dose (81 mg/day) aspirin

Where it is running

• Memorial Medical Center Cancer Services — Modesto, California, United States
• Salinas Valley Memorial Hospital — Salinas, California, United States
• Stanford Comprehensive Cancer Center at Stanford University Medical Center — Stanford, California, United States
• Aurora Presbyterian Hospital — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Memorial Hospital — Colorado Springs, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• CCOP - Colorado Cancer Research Program, Incorporated — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
• St. Mary-Corwin Regional Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Praxair Cancer Center at Danbury Hospital — Danbury, Connecticut, United States
• William W. Backus Hospital — Norwich, Connecticut, United States
• Halifax Medical Center - Daytona Beach — Daytona Beach, Florida, United States
• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• Veterans Affairs Medical Center - Augusta — Augusta, Georgia, United States
• MBCCOP - Medical College of Georgia Cancer Center — Augusta, Georgia, United States
• Hembree Mercy Cancer Center at St. Edward Mercy Medical Center — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

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