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A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)

Phase 3
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)


I. Compare the survival and time to progression of patients with stage IIIA or IIIB
non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy
with or without thalidomide.

II. Evaluate the toxicity of the thalidomide-containing regimen and compare response rates
of the two groups.

III. Determine whether the inactivation of p16, Death-associated protein kinase
(DAP-kinase), O6-methylguanine-DNA methyltransferase (MGMT) gene, or tissue-inhibitor of
metalloproteinase 3 (TIMP-3) genes can be used to predict survival in these patients treated
with this regimen.

IV. Determine whether the detection of a methylation biomarker in serum can be used to
predict survival in these patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are stratified according to disease histology
(squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and
time of randomization (before addition of chemoradiotherapy vs after). Patients are
randomized to one of two treatment arms.

ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours immediately followed by
carboplatin IV over 15-30 minutes on days 1 and 22. Treatment continues every 22 days in the
absence of unacceptable toxicity or disease progression.

ARM B: Patients receive paclitaxel and carboplatin as in arm A. Patients also receive oral
thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the
absence of disease progression.

Beginning between days 43-50, patients in both arms with stable or responding disease
receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30
minutes once weekly for 6 weeks and radiotherapy (RT) 5 days a week for 6 weeks. Arm B
patients continue oral thalidomide.

Patients are followed every 2 months for 2 years and then every 6 months for 3 years.

Inclusion Criteria:

- 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


- 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

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Time

Outcome Description:

Survival time is defined as time from study entry to death from any cause

Outcome Time Frame:

every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5

Safety Issue:


Principal Investigator

Joan H. Schiller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2000

Completion Date:

May 2011

Related Keywords:

  • Lung Cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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