Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00014196

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: docetaxel Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Docetaxel

U.S. FDA Resources

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

Study Start Date:

March 2001

Detailed Description:

OBJECTIVES:

Determine survival and time to treatment failure in patients with stage IIIB non-small cell lung cancer treated with induction docetaxel, cisplatin, and radiotherapy followed by consolidation docetaxel.
Determine the response rate in these patients when treated with this regimen.
Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks.

At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy, patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed stage IIIB non-small cell lung cancer
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
Pathologically or radiographically documented positive N3 nodes
- No positive supraclavicular or scalene lymph nodes with disease extending into the cervical region OR
T4 tumor invading any of the following:
- Mediastinum
- Heart
- Great vessels
- Trachea
- Esophagus
- Vertebral body
- Carina
No brain, contralateral chest, liver, or adrenal metastases
No more than 1 parenchymal lesion
No malignant pleural effusions unless they are only visible on CT scan or deemed too small to tap
No pericardial effusions
Measurable disease

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Not specified

Renal:

Creatinine clearance at least 50 mL/min

Pulmonary:

One of the following:
- FEV1 at least 2.0 L
- Predicted FEV1 of contralateral lung greater than 800 mL
- Predicted post-treatment FEV1 at least 1.0 L

Other:

No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent growth factors during induction chemoradiotherapy

Chemotherapy:

No prior chemotherapy for lung cancer

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy for lung cancer

Surgery:

No prior surgical resection of lung cancer
Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery for determining diagnosis, stage, or potential resectability allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014196

Show 97 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Raja Mudad, MD, FACP

Tulane University Health Sciences Center

More Information

Additional Information:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00014196 History of Changes
Other Study ID Numbers:	CDR0000068516, SWOG-S0022
Study First Received:	April 10, 2001
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

squamous cell lung cancer
large cell lung cancer
stage IIIB non-small cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012