Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004859

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: paclitaxel Drug: thalidomide Radiation: radiation therapy	Phase III

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

Drug Information available for: Thalidomide Paclitaxel Carboplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III NSCLC

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival at median [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression at median [ Designated as safety issue: No ]
Response rate at best response to treatment [ Designated as safety issue: No ]

Estimated Enrollment:	588
Study Start Date:	January 2000

Detailed Description:

OBJECTIVES:

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.
Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups.
Determine whether the inactivation of p16, DAP-kinase, MGMT, or TIMP-3 genes can be used to predict survival in these patients treated with this regimen.
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 I: Patients receive paclitaxel 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 II: Patients receive paclitaxel and carboplatin as in arm I. 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 5 days a week for 6 weeks. Arm II patients continue oral thalidomide.

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

PROJECTED ACCRUAL: A total of 588 patients will be accrued for this study within 7 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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 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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Platelet count at least 100,000/mm^3
WBC at least 4,000/mm^3 OR
Absolute neutrophil count at least 2,000/mm^3

Hepatic:

Bilirubin normal
SGOT no greater than 2.5 times upper limit of normal

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular:

No uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year
No serious cardiac arrhythmias requiring medication

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy
No other active malignancies
No serious uncontrolled active infection
No evidence of greater than grade 1 neuropathy by history or physical examination
No history of seizure disorders
No contraindication to daily low-dose (81 mg/day) aspirin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Concurrent filgrastim (G-CSF) allowed for persistent neutropenia

Chemotherapy:

At least 5 years since prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy to only area of measurable or active tumor

Surgery:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004859

Show 236 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Joan H. Schiller, MD

Simmons Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Belinsky SA, Grimes MJ, Casas E, Stidley CA, Franklin WA, Bocklage TJ, Johnson DH, Schiller JH. Predicting gene promoter methylation in non-small-cell lung cancer by evaluating sputum and serum. Br J Cancer. 2007 Apr 23;96(8):1278-83. Epub 2007 Apr 3.

Belinsky SA, Grimes M, Johnson D, et al.: Predicting gene promoter methylation in lung tumors through examination of sputum and serum. [Abstract] J Clin Oncol 24 (Suppl 18): A-7208, 416s, 2006.

Study ID Numbers:	CDR0000067510, ECOG-3598
Study First Received:	March 7, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004859 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Thoracic Neoplasms
Immunologic Factors
Thalidomide
Adenocarcinoma, Bronchiolo-Alveolar
Antimitotic Agents
Carboplatin
Angiogenesis Inhibitors
Immunosuppressive Agents
Carcinoma
Anti-Bacterial Agents
Respiratory Tract Diseases

Lung Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Growth Substances
Mitosis Modulators
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung

ClinicalTrials.gov processed this record on May 07, 2009