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Lung CancerPhase 3NCT00863512

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

A Phase 3 study testing cisplatin, docetaxel and gemcitabine hydrochloride in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 94 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
cisplatin, docetaxel and gemcitabine hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
94 sitesin 2 countries
Study dates
Mar 2009to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

94 sites in 2 countries.

94 sites in 2 countries

United States93 sites

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Regional Medical Center

    Anniston, Alabama, 36207

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

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

    Bethlehem, Pennsylvania, 18015

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

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

    Boston, Massachusetts, 02115

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

    Burbank, California, 91505

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

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

    Columbus, Ohio, 43210-1240

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

    Concord, New Hampshire, 03301

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Easton Regional Cancer Center at Easton Hospital

    Easton, Pennsylvania, 18042

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology-Oncology, PC - Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

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

    Green Bay, Wisconsin, 54301-3526

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

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Lynchburg Hematology-Oncology Clinic

    Lynchburg, Virginia, 24501

  • Holy Family Memorial Medical Center Cancer Care Center

    Manitowoc, Wisconsin, 54221-1450

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Michiana Hematology-Oncology, PC - South Bend

    Mishawaka, Indiana, 46545-1470

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

  • Jameson Memorial Hospital - North Campus

    New Castle, Pennsylvania, 16105

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • Michiana Hematology Oncology PC - Niles

    Niles, Michigan, 49120

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • Study site

    Pismo Beach, California, 93449

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Michiana Hematology Oncology PC - Plymouth

    Plymouth, Indiana, 46563

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

    Pomona, California, 91767

  • Saint Francis Hospital Cancer Center

    Poughkeepsie, New York, 12601

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

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

    Savannah, Georgia, 31405

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough

    Scarborough, Maine, 04074

  • St. Nicholas Hospital

    Sheboygan, Wisconsin, 53081

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Franciscan Cancer Center at St. Joseph Medical Center

    Tacoma, Washington, 98405-3004

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • Cancer Institute at St. Joseph Medical Center

    Towson, Maryland, 21204

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Faxton Regional Cancer Center

    Utica, New York, 13502

  • Michiana Hematology Oncology PC - La Porte

    Westville, Indiana, 46391

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

Australia1 site

  • St. Vincent's Hospital - Melbourne

    Fitzroy, Victoria, 3065

Other trials in Australia

About this study

Official title: A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data

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.

Read the 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
Being tested
cisplatin, docetaxel, gemcitabine hydrochloride, pemetrexed disodium, vinorelbine tartrate
Keywords
stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00863512
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: cisplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium; Drug: vinorelbine tartrate
Arm IIExperimentalPatients receive standard care (observation).
Receives: Procedure: standard follow-up care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

    Measured: Up to 12 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionNov 2011
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00863512
Sponsor's protocol ID
CALGB-30506
Other IDs
CALGB-30506, CDR0000636895
Status last verified
Feb 2017
First submitted
17 Mar 2009
Last updated
27 Mar 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, docetaxel and gemcitabine hydrochloride in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 94 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Up to 12 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00863512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.

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