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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00041314




Registration number
NCT00041314
Ethics application status
Date submitted
8/07/2002
Date registered
27/01/2003
Date last updated
15/06/2023

Titles & IDs
Public title
Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
Scientific title
A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
E-E1501
Secondary ID [2] 0 0
CDR0000069467
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - carboplatin
Treatment: Drugs - exisulind
Treatment: Drugs - gemcitabine hydrochloride

Treatment: Drugs: carboplatin


Treatment: Drugs: exisulind


Treatment: Drugs: gemcitabine hydrochloride
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed non-small cell lung cancer (NSCLC)

- Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined
modality therapy OR

- Stage IV

- Prior brain metastases are allowed provided the following are true:

- Patient completed radiotherapy and/or surgery at least 3 weeks prior to study

- Objective evidence of resolution or significant improvement of brain lesions
exists on follow-up CT scan or MRI

- Patient is neurologically improved or stable

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- WBC at least 3,000/mm^3

- Hemoglobin at least 9 g/L

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.25 mg/dL

- SGOT no greater than 1.5 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 50 mL/min

Cardiovascular:

- No prior uncontrolled cardiovascular disease

- No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart
failure within the past 3 months

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective nonhormonal contraception

- No serious active infection

- No dementia or active psychoses

- No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in
situ of the cervix, or cancer curatively treated with surgery or small-field
radiotherapy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

Other:

- At least 1 month since prior investigational agents

- More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors,
or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen)

- No concurrent sulindac or COX-2 inhibitors
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
NSW Breast Cancer Institute - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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Colorado
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Delaware
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District of Columbia
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United States of America
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Florida
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Georgia
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United States of America
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Illinois
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Indiana
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Iowa
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New York
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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South Dakota
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Tennessee
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United States of America
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Wisconsin
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Puerto Rico
State/province [30] 0 0
San Juan
Country [31] 0 0
South Africa
State/province [31] 0 0
Pretoria

Funding & Sponsors
Primary sponsor type
Other
Name
Eastern Cooperative Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind
in treating patients who have advanced non-small cell lung cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00041314
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory A. Masters, MD
Address 0 0
NorthShore University HealthSystem
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00041314