Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

NCT ID: NCT00863512

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-11-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

• To determine the potential overall survival benefit of adjuvant chemotherapy in patients with early stage non-small cell lung cancer (NSCLC) randomized to chemotherapy compared to those randomized to the present standard of care (observation).
• To collect and process high-quality fresh frozen lung cancer tumor tissue for gene expression array generation from multiple institutions.

Secondary

• To evaluate selected genomic-based lung cancer prognostic models using data from the patients randomized to observation after resection.
• To characterize the rate of chemotherapy toxicity for the different chemotherapy treatment regimens.
• To assess quality of life (QOL) in early stage patients periodically after resection for NSCLC.
• To examine the impact of chemotherapy on QOL for patients receiving chemotherapy, as compared to patients in the observation arm.

OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage (I vs II) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms within 12 weeks after surgery.

All patients undergo complete resection of disease (i.e., lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy, but not segmentectomy or wedge resection).

• Arm I: Patients receive 1 of 3 chemotherapy regimens. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

• Regimen 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1.
• Regimen 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60 minutes on day 1.
• Regimen 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1.
• Regimen 4: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 60 minutes on day 1.
• Arm II: Patients receive standard care (observation). Tissue obtained at surgery is examined by RNA microarray analysis. A Lung Metagene Score (LMS) is determined for each patient and correlated with survival and response.

After completion of study treatment, patients are followed every 6 months for 5 years and then once a year for 7 years.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Given IV

docetaxel

Intervention Type: DRUG

Given IV

gemcitabine hydrochloride

Intervention Type: DRUG

Given IV

pemetrexed disodium

Intervention Type: DRUG

Given IV

vinorelbine tartrate

Intervention Type: DRUG

Given IV

Arm II

Patients receive standard care (observation).

Group Type: EXPERIMENTAL

standard follow-up care

Intervention Type: PROCEDURE

Standard care

Interventions

cisplatin

Given IV

Intervention Type: DRUG

docetaxel

Given IV

Intervention Type: DRUG

gemcitabine hydrochloride

Given IV

Intervention Type: DRUG

pemetrexed disodium

Given IV

Intervention Type: DRUG

vinorelbine tartrate

Given IV

Intervention Type: DRUG

standard follow-up care

Standard care

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

• Any variant allowed (e.g., pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma)
• Primary tumor must be T1a, T1b, T2a, or T2b by AJCC 7.0
• No status
• Tumor measuring ≥ 2.0 cm but ≤ 7.0 cm in diameter by CT scan

• The mass must have a source document to verify tumor size in the greatest dimension, which includes a CT scan report, a clinic note from the enrolling physician, and/or a printed image with caliper measurements on the lung mass
• Node-negative disease

• Evidence of hilar or mediastinal node involvement by chest CT scan (> 1 cm diameter) must be assessed with mediastinoscopy, endo-esophageal ultrasound with biopsy, endo-bronchial ultrasound, bronchoscopy, or mediastinal nodal sampling before or at time of thoracotomy
• No locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Granulocytes ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Bilirubin ≤ 1.5 mg/dL
• AST < 1.5 times upper limit of normal (ULN)
• Serum creatinine ≤ 1.5 times ULN
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No history of prior or concurrent malignancy, except curatively treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease-free for 3 years

PRIOR CONCURRENT THERAPY:

• More than 3 years since prior cytotoxic or anticancer treatment
• No concurrent treatment with hormones or other chemotherapeutic agents, except steroids given for adrenal failure, hormone administered for nondisease-related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic
• No concurrent thoracic radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David H. Harpole, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Regional Medical Center

Anniston, Alabama, United States

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Burbank, California, United States

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, United States

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Pismo Beach, California, United States

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

Pomona, California, United States

Helen and Harry Gray Cancer Center at Hartford Hospital

Hartford, Connecticut, United States

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, United States

Resurrection Medical Center

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Elkhart Clinic, LLC

Elkhart, Indiana, United States

Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, United States

Elkhart General Hospital

Elkhart, Indiana, United States

Howard Community Hospital

Kokomo, Indiana, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, United States

Saint Joseph Regional Medical Center

Mishawaka, Indiana, United States

Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, United States

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Michiana Hematology Oncology PC - La Porte

Westville, Indiana, United States

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, United States

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, United States

Greater Baltimore Medical Center Cancer Center

Baltimore, Maryland, United States

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, United States

Cancer Institute at St. Joseph Medical Center

Towson, Maryland, United States

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, United States

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Newton-Wellesley Hospital

Newton, Massachusetts, United States

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, United States

Dickinson County Healthcare System

Iron Mountain, Michigan, United States

Borgess Medical Center

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Michiana Hematology Oncology PC - Niles

Niles, Michigan, United States

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, United States

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, United States

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, United States

Cancer Resource Center - Lincoln

Lincoln, Nebraska, United States

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

Immanuel Medical Center

Omaha, Nebraska, United States

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, United States

Creighton University Medical Center

Omaha, Nebraska, United States

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

Concord, New Hampshire, United States

New Hampshire Oncology - Hematology, PA - Hooksett

Hooksett, New Hampshire, United States

Saint Francis Hospital Cancer Center

Poughkeepsie, New York, United States

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Faxton Regional Cancer Center

Utica, New York, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Kinston Medical Specialists

Kinston, North Carolina, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Mercy Cancer Center at Mercy Medical Center

Canton, Ohio, United States

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, United States

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, United States

St. Luke's Cancer Network at St. Luke's Hospital

Bethlehem, Pennsylvania, United States

Easton Regional Cancer Center at Easton Hospital

Easton, Pennsylvania, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Jameson Memorial Hospital - North Campus

New Castle, Pennsylvania, United States

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Medical City Dallas Hospital

Dallas, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Lynchburg Hematology-Oncology Clinic

Lynchburg, Virginia, United States

Providence Centralia Hospital

Centralia, Washington, United States

St. Francis Hospital

Federal Way, Washington, United States

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, United States

Good Samaritan Cancer Center

Puyallup, Washington, United States

Franciscan Cancer Center at St. Joseph Medical Center

Tacoma, Washington, United States

Allenmore Hospital

Tacoma, Washington, United States

CCOP - Northwest

Tacoma, Washington, United States

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, United States

St. Clare Hospital

Tacoma, Washington, United States

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, United States

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Holy Family Memorial Medical Center Cancer Care Center

Manitowoc, Wisconsin, United States

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, United States

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, United States

St. Nicholas Hospital

Sheboygan, Wisconsin, United States

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

St. Vincent's Hospital - Melbourne

Fitzroy, Victoria, Australia

Countries

United States; Australia

Other Identifiers

CALGB-30506

Identifier Type: -

Identifier Source: secondary_id

CDR0000636895

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-30506

Identifier Type: -

Identifier Source: org_study_id