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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/NCT00006004




Registration number
NCT00006004
Ethics application status
Date submitted
5/07/2000
Date registered
27/01/2003
Date last updated
15/06/2023

Titles & IDs
Public title
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
Scientific title
A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
Secondary ID [1] 0 0
E-1599
Secondary ID [2] 0 0
CDR0000068012
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 - cisplatin
Treatment: Drugs - gemcitabine hydrochloride
Treatment: Drugs - paclitaxel

Treatment: Drugs: carboplatin


Treatment: Drugs: cisplatin


Treatment: Drugs: gemcitabine hydrochloride


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

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung carcinoma of any of the
following subtypes:

- Squamous cell

- Adenocarcinoma

- Large cell anaplastic

- Bronchioalveolar

- Non-small cell carcinoma not otherwise specified

- No small cell anaplastic elements allowed

- Must have:

- Recurrent disease after prior radiotherapy or surgery OR

- Stage IV disease with distant metastases OR

- Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest
x-ray or pleural implants documented pathologically or on CT or chest x-ray

- Bidimensionally measurable or evaluable disease

- Brain metastases allowed provided clinically stable after treatment with surgery
and/or radiotherapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 5 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No uncontrolled high blood pressure, unstable angina, or congestive heart failure

- No myocardial infarction within the past 6 months

- No serious ventricular arrhythmias requiring medication

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other active malignancies requiring ongoing treatment

- No uncontrolled serious active infections

- No suspected hypersensitivity to agents that utilize Cremophor

- No evidence of neuropathy grade 2 or greater by history or physical examination

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for non-small cell lung cancer

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy to only site of measurable or evaluable disease unless
subsequent progression documented by physical exam, radiograph, or pathology

- Recovered from prior radiotherapy

- No concurrent radiotherapy except for whole brain radiation for developing brain
metastases

Surgery:

- See Disease Characteristics
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
Randomised controlled trial
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
22/08/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - 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
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New Mexico
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Peru
State/province [11] 0 0
Lima
Country [12] 0 0
Puerto Rico
State/province [12] 0 0
San Juan

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. It is not
yet known which combination chemotherapy regimen is more effective for treating non-small
cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two combination
chemotherapy regimens in treating patients who have non-small cell lung cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00006004
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Corey J. Langer, MD
Address 0 0
Fox Chase Cancer Center
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/NCT00006004