Lung CancerPhase 2NCT00005865
Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing vinorelbine tartrate in people with Lung Cancer, run by GlaxoSmithKline at 50 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. It is not yet known whether giving vinorelbine by mouth or infusion is more effective in treating non- small cell lung cancer. 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?
- vinorelbine tartrate
- How many people
- Not given
- Where
- 50 sitesin 3 countries
- Study dates
- Apr 2000to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 or cytologically confirmed stage IIIB or IV non-small cell lung cancer not amenable to combination chemotherapy, curative surgery, or radiotherapy Bidimensionally measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN Alkaline phosphatase less than 5 times ULN (except in cases of bone or liver metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable or uncontrolled cardiac disease Pulmonary: No history of recurrent aspiration pneumonitis within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 9 days after study Able to swallow capsules intact No active infection within the past 2 weeks No unstable or uncontrolled medical conditions No other prior malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No history of peripheral neuropathy with severity greater than CALGB grade 1
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunologic therapy At least 1 week since prior hematopoietic growth factors or other blood products Chemotherapy: See Disease Characteristics No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior surgery Other: At least 4 weeks since prior investigational device or drug No other concurrent anticancer therapy No other concurrent investigational device or drug
Trial locations and contacts
50 sites in 3 countries.
50 sites in 3 countries
United States46 sites
Lovelace Health Systems
Albuquerque, New Mexico, 87108
Medical Oncology, LLC
Baton Rouge, Louisiana, 70808
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Office of Janak K. Choksi
Burlington, North Carolina, 27216
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Hematology Oncology Consultants Inc
Columbus, Ohio, 43235
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
Medical Group of Texas
Dallas, Texas, 75243
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
St. Luke's Hospital
Duluth, Minnesota, 55805
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
NorthBay Healthcare System
Fairfield, California, 94533
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, 72703
Office of Hal Gerstein
Great Neck, New York, 11022
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Northern NJ Cancer Associates
Hackensack, New Jersey, 07601
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Office of Luis Alberto Meza
Lafayette, Louisiana, 70503
Sparrow Regional Cancer Center
Lansing, Michigan, 48909
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510-4844
Joe Arrington Cancer Center
Lubbock, Texas, 79410
HillCrest Hospital
Mayfield Heights, Ohio, 44124
West Clinic, P.C.
Memphis, Tennessee, 38117
Memphis Cancer Center
Memphis, Tennessee, 38119
Saint Vincents Comprehensive Breast Center
New York, New York, 10011
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Veterans Affairs Medical Center - Northport
Northport, New York, 11768
West Florida Cancer Institute - Pensacola
Pensacola, Florida, 32514
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
Berkshire Physicians and Surgeons, P.C.
Pittsfield, Massachusetts, 01201
Wilshire Oncology Medical Center
Pomona, California, 91767
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, 27609
Cancer Care Consultants of Northern California
Redding, California, 96009-3100
University of Rochester Cancer Center
Rochester, New York, 14642
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
South Bend Clinic and SurgiCenter
South Bend, Indiana, 46634
Providence Hospital Cancer Center
Southfield, Michigan, 48075
Washington University Barnard Cancer Center
St Louis, Missouri, 63110
Mercy Oncology-Hematology Limited
St Louis, Missouri, 63141
MultiCare Hematolgy/Oncology Clinic
Tacoma, Washington, 98405
Arizona Clinical Research Center
Tucson, Arizona, 85712
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
Canada2 sites
McGill University
Montreal, Quebec, H2W 1S6
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Puerto Rico2 sites
Veterans Affairs Medical Center - San Juan
San Juan, 00927-5800
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, 00936-5067
About this study
Official title: A Research Study Evaluating Oral and Intravenous NAVELBINE as a Single Agent for the Treatment of Chemotherapy-Naive Subjects With Inoperable Stage IIIb or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. It is not yet known whether giving vinorelbine by mouth or infusion is more effective in treating non- small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Compare the safety and efficacy of oral versus intravenous vinorelbine in patients with stage IIIB or IV non-small cell lung cancer. II. Compare the quality of life of patients treated with these regimens. III. Compare the pharmacokinetics of these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral vinorelbine weekly. Arm II: Patients receive vinorelbine IV over 10 minutes weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed several times during treatment and 4 weeks after treatment. Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A maximum of 195 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- vinorelbine tartrate
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinorelbine tartrateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2004 (estimated)
- Study startApr 2000
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tess Delacruz, RN, BSN, Study chair, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005865
- Sponsor's protocol ID
- CDR0000067897
- Other IDs
- GW-VINA2004
- Status last verified
- Jun 2007
- First submitted
- 2 Jun 2000
- Last updated
- 6 Jan 2014
- Results posted
- No
Publications
Hirsh V, Desjardins P, Needles BM, Rigas JR, Jahanzeb M, Nguyen L, Zembryki D, Leopold LH. Oral versus intravenous administration of vinorelbine as a single agent for the first-line treatment of metastatic nonsmall cell lung carcinoma (NSCLC): A randomized phase II trial. Am J Clin Oncol. 2007 Jun;30(3):245-51. doi: 10.1097/01.coc.0000256103.21797.e5.
PubMed 17551300
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research Study Evaluating Oral and Intravenous NAVELBINE as a Single Agent for the Treatment of Chemotherapy-Naive Subjects With Inoperable Stage IIIb or Stage IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00005865
- Acronym / sponsor ID
- CDR0000067897
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Study completion
- Jun 2007 (actual)
- First posted
- 24 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. It is not yet known whether giving vinorelbine by mouth or infusion is more effective in treating non- small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES: I. Compare the safety and efficacy of oral versus intravenous vinorelbine in patients with stage IIIB or IV non-small cell lung cancer. II. Compare the quality of life of patients treated with these regimens. III. Compare the pharmacokinetics of these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral vinorelbine weekly. Arm II: Patients receive vinorelbine IV over 10 minutes weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed several times during treatment and 4 weeks after treatment. Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A maximum of 195 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vinorelbine tartrate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Results publication: PubMed 17551300Hirsh V, Desjardins P, Needles BM, Rigas JR, Jahanzeb M, Nguyen L, Zembryki D, Leopold LH. Oral versus intravenous administration of vinorelbine as a single agent for the first-line treatment of metastatic nonsmall cell lung carcinoma (NSCLC): A randomized phase II trial. Am J Clin Oncol. 2007 Jun;30(3):245-51. doi: 10.1097/01.coc.0000256103.21797.e5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tess Delacruz, RN, BSN study chair
GlaxoSmithKline
50 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vinorelbine tartrate in people with Lung Cancer, run by GlaxoSmithKline at 50 sites in 3 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: finished, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Canada, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005865, which also lists 1 linked publication.
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 6 Jan 2014.