S0023: Combination Chemo Plus RT With or Without Gefitinib in Treating Patients With Unresectable Stage III NSCLC - Full Text View

Sponsor:	Southwest Oncology Group
Collaborators:	National Cancer Institute (NCI) North Central Cancer Treatment Group NCIC Clinical Trials Group
Information provided by:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00020709

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. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: docetaxel Drug: etoposide Drug: gefitinib Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase III Trial Of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed By Maintenance Therapy With ZD 1839 Or Placebo In Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Docetaxel Etoposide phosphate ZD1839

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Study Start Date:	June 2001
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare cisplatin, etoposide, radiotherapy, and docetaxel with or without gefitinib, in terms of improving overall survival and progression-free survival, in patients with unresectable stage III non-small cell lung cancer.
Determine the toxicity profile of gefitinib in these patients.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to performance status (0 vs 1), stage (stage IIIA vs IIIB), measurability of lesion (measurable vs nonmeasurable), and histologic subtype (squamous vs nonsquamous).

Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning within 24 hours after starting chemotherapy, patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 1.5 weeks.

Beginning approximately 4-8 weeks after completion of chemoradiotherapy, patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 3 courses.

Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy. Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy.

Arm I: Patients receive oral gefitinib daily.
Arm II: Patients receive oral placebo daily. In both arms, maintenance therapy continues for a maximum of 5 years in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 5 years and then annually for 5 years.

PROJECTED ACCRUAL: A total of 840 patients will be accrued for this study within 3.5 years.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed newly diagnosed single, primary bronchogenic non-small cell lung cancer (NSCLC)
- Adenocarcinoma
- Non-lobar and non-diffuse bronchoalveolar cell carcinoma
- Large cell carcinoma
- Squamous cell carcinoma
Unresectable stage IIIA disease
- Histologically or cytologically confirmed N2 status
- Multiple and/or bulky mediastinal lymph nodes on CT scan or x-ray
- Ineligible for induction chemotherapy or chemoradiotherapy followed by surgical resection
- Ineligible for or refused participation in SWOG-9336 OR
Stage IIIB disease
- Pathologically or radiographically documented positive N3 nodes
  - No positive supraclavicular or scalene lymph nodes with disease extending up into the cervical region OR
- Any documented T4 lesions invading the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina
  - Mediastinal involvement without organ involvement allowed if soft tissue mass extends directly into the mediastinum
  - Radiographic criteria for involvement of main pulmonary artery allowed if mediastinal soft tissue mass is present
Single primary parenchymal lesion
- No other lesions on same or opposite sides of the lung
- No metastatic disease involving the contralateral chest, liver, or adrenals by CT scan of upper abdomen
No malignant pleural or pericardial effusions
- Pleural effusions visible only on CT scan or too small to tap allowed
Measurable or evaluable disease by CT scan, MRI, x-ray, or physical exam
No brain metastases

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm^3
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:

FEV_1 at least 2.0 L OR
FEV_1 less than 2.0 L if predicted FEV_1 of the contralateral lung is greater than 800 mL by quantitative split function testing

Other:

No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No other concurrent non-cancer-related illness that would preclude study therapy
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent colony-stimulating factors during induction therapy

Chemotherapy:

See Disease Characteristics
No prior chemotherapy for NSCLC

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
No prior radiotherapy for NSCLC

Surgery:

No prior surgical resection of NSCLC
Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar diagnostic or staging surgery allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020709

Show 176 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

North Central Cancer Treatment Group

NCIC Clinical Trials Group

Investigators

Study Chair:	Karen Kelly, MD	University of Colorado, Denver
Study Chair:	James R. Jett, MD	Mayo Clinic
Study Chair:	Yee C. Ung, MD, FRCPC	Edmond Odette Cancer Centre at Sunnybrook

More Information

Additional Information:

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

Publications:

Kelly K, Chansky K, Gaspar LE, Albain KS, Jett J, Ung YC, Lau DH, Crowley JJ, Gandara DR. Phase III Trial of Maintenance Gefitinib or Placebo After Concurrent Chemoradiotherapy and Docetaxel Consolidation in Inoperable Stage III Non-Small-Cell Lung Cancer: SWOG S0023. J Clin Oncol. 2008 Mar 31; [Epub ahead of print]

Kelly K, Chansky K, Gaspar LE, et al.: Updated analysis of SWOG 0023: a randomized phase III trial of gefitinib versus placebo maintenance after definitive chemoradiation followed by docetaxel in patients with locally advanced stage III non-small cell lung cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-7513, 388s, 2007.

Gaspar LE, McCoy J, Kelly K, et al.: Analysis of V20 and radiation pneumonitis on SWOG0023: a phase III trial of concurrent chemoradiation and docetaxel consolidation in stage III non-small cell lung cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-108, S61-2, 2006.

Kelly K, Gaspar LE, Chansky K, et al.: Low incidence of pneumonitis on SWOG 0023: a preliminary analysis of an ongoing phase III trial of concurrent chemoradiotherapy followed by consolidation docetaxel and Iressa/placebo maintenance in patients with inoperable stage III non-small cell lung cancer. [Abstract] J Clin Oncol 23 (Suppl 16): A-7058, 634s, 2005.

Responsible Party:	Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00020709 History of Changes
Other Study ID Numbers:	CDR0000068706, SWOG-S0023, CAN-NCIC-BR15, NCCTG-S0023
Study First Received:	July 11, 2001
Last Updated:	July 18, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:

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
bronchoalveolar cell lung cancer

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
Etoposide phosphate
Docetaxel

Gefitinib
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012