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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/NCT00077415




Registration number
NCT00077415
Ethics application status
Date submitted
10/02/2004
Date registered
12/02/2004
Date last updated
15/05/2013

Titles & IDs
Public title
3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Stage III or Stage IV Recurrent Non-Small Cell Lung Cancer
Scientific title
A Randomized Phase II Study Of Triapine® Alone Versus Triapine and Gemcitabine As Second-Line Treatment Of Advanced Non-Small-Cell-Lung Cancer In Patients Who Had Prior Gemcitabine With Evaluation Of The Effect Of Triapine® On Gemcitabine Pharmacokinetics and Cellular Uptake In Peripheral Mononuclear Cells
Secondary ID [1] 0 0
CDR0000350313
Secondary ID [2] 0 0
CTRG-LUN012
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 - gemcitabine hydrochloride
Treatment: Drugs - triapine

Treatment: Drugs: gemcitabine hydrochloride


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

Outcomes
Primary outcome [1] 0 0
Objective tumor response as assessed by RECIST criteria
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Toxicity as assessed by NCI CTCAE v3.0
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Median time to progression
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Duration of overall response
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Pharmacokinetics
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed* non-small cell lung cancer (NSCLC)

- Stage III or IV disease

- One of the following cellular types:

- Adenocarcinoma

- Non-diffuse bronchoalveolar cell carcinoma

- Large cell carcinoma

- Squamous cell carcinoma NOTE: *A repeat biopsy of any accessible tumor site
is required if > 5 years have elapsed since the initial diagnosis

- Progressive disease after 1 prior gemcitabine-containing chemotherapy regimen for
stage III or IV NSCLC and must have achieved, at least once, a partial response,
complete response, or stable disease during therapy

- Not a primary non-responder and experienced only progressive disease during
gemcitabine-containing chemotherapy

- Measurable disease

- At least 1 unidimensionally measurable lesion = 20 mm by conventional techniques
OR = 10 mm by spiral CT scan

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- Not specified

Hematopoietic

- WBC = 3,000/mm^3

- Absolute neutrophil count = 1,500/mm^3

- Platelet count = 100,000/mm^3

- No glucose-6-phosphate dehydrogenase (G6PD) deficiency

Hepatic

- Bilirubin = 1.5 times upper limit of normal (ULN)

- ALT = 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

- Creatinine = 1.5 times ULN OR

- Creatinine clearance = 50 mL/min

Cardiovascular

- No prior uncontrolled cardiac disease

- No myocardial infarction within the past 12 months

- No symptomatic congestive heart failure

- No coronary artery disease

- No cardiac arrhythmia

Pulmonary

- No uncontrolled symptomatic pulmonary disease

- No pulmonary disease that requires oxygen therapy

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except completely treated carcinoma in
situ of the cervix or nonmelanoma skin cancer

- No prior allergic reaction attributed to compounds of similar chemical or biological
composition to study agents

- No other concurrent uncontrolled illness

- No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

Endocrine therapy

- Not specified

Radiotherapy

- More than 4 weeks since prior radiotherapy and recovered

Surgery

- Not specified

Other

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

- No other concurrent anticancer agents or therapies
Minimum age
18 Years
Maximum age
No limit
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
Open (masking not 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
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
31
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Perth - Perth
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Shatin, New Territories
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Cancer Therapeutics Research 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, such as 3-AP and gemcitabine, work in different ways
to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may
kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine as
second-line therapy works in treating patients with recurrent stage III or stage IV non-small
cell lung cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00077415
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brigette Ma, MD
Address 0 0
Prince of Wales Hospital
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/NCT00077415