Randomized phase2 Study of IP vs. GP as the First-line Therapy Followed by Two Different Sequences as the 2nd or 3rd-line Therapy for Patients With Advanced NSCLC;
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
Randomized phase2 Study of IP vs. GP as the First-line Therapy Followed by Two Different Sequences as the 2nd or 3rd-line Therapy for Patients With Advanced NSCLC;
Cisplatin-based chemotherapy is currently considered to be the standard treatment in
advanced non-small cell lung cancer (NSCLC). However, overall response is only 30-40%,
suggesting that a majority of the patients do not respond to platinum. Subsequently, those
patients who experience treatment failure with platinum-based therapy typically received
pemetrexed or docetaxel as second-line treatment, with response rate of approximately 7% to
10%. The primary objective of this randomized phase II study is to compare the Response Rate
of each sequence of treatment approach in patients with advanced NSCLC. Additionally,
development of gene expression profiles and genotypes that can predict response to commonly
used chemotherapy may provide a unique opportunity to better utilize drugs shown to be
effective in first- or second-line therapy. Here, we will conduct a pharmacogenomic study to
provide rational approach to the treatment of NSCLC by developing predictors of cisplatin
(first-line agent) and pemetrexed or docetaxel (second-line agents) sensitivity and
demonstrating the clinical value of identifying the most appropriate drug on the basis of
sensitivity profile for the treatment regimen of each individual patient. Such an approach
is likely to maximize response to chemotherapy and may change the current empirical paradigm
of NSCLC therapy.
Inclusion Criteria:
- Histologic diagnosis of NSCLC, Stage IV or selected stage IIIB (malignant pleural or
pericardial effusion or supraclavicular adenopathy) according to the American Joint
Committee on Cancer (AJCC).
- Adequate tumor tissues for ERCC1 analysis.
- No prior chemotherapy.
- Prior radiation therapy is allowed as long as the irradiated area is not the only
source of measurable disease.
- No other forms of cancer therapy, such as radiation, immunotherapy and major surgery
for at least 3 weeks before the enrollment in study.
- Performance status of 0, 1, or 2 on the ECOG criteria.
- Measurable disease, according to the Response Evaluation Criteria in Solid
Tumors(RECIST), the presence of at least one unidimensionally measurable lesion with
longest diameter 10mm by spiral CT scan.
- Estimated life expectancy of at least 12 weeks.
- Patient compliance that allow adequate follow-up.
- Adequate hematologic and renal function.
- Informed consent from patient or patient's relative.
- Males or females at least 18 years of age.
- No pregnancy or breast feeding.
- Patients with brain metastasis are allowed unless there were clinically significant
neurological symptoms or signs
Exclusion Criteria:
- MI within preceding 6 months or symptomatic heart disease, including unstable angina,
congestive heart failure or uncontrolled arrhythmia.
- Serious concomitant infection.
- Second primary malignancy (except in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin or prior malignancy treated more than 5
years ago without recurrence).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate
Outcome Time Frame:
every 6 weeks
Safety Issue:
No
Principal Investigator
JI-YOUN HAN, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Center
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
NCCCTS-08-371
NCT ID:
NCT01003964
Start Date:
February 2009
Completion Date:
July 2013
Related Keywords:
- Non Small Cell Lung Cancer
- NON-SMALL CELL LUNG CANCER
- excision repair cross-complementing 1
- Gemcitabine and cisplatin
- Irinotecan and cisplatin
- Pemetrexed
- Docetaxel
- advanced NSCLC
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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