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Pharmacogenomic Study for Providing Personalized Strategy to the Treatment of Non-small Cell Lung Cancer (NSCLC) IIIB/IV

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ClinicalTrials.gov Identifier: NCT01003964
Recruitment Status : Unknown
Verified November 2013 by Ji-youn Han, National Cancer Center, Korea.
Recruitment status was:  Active, not recruiting
First Posted : October 29, 2009
Last Update Posted : November 14, 2013
Sponsor:
Information provided by (Responsible Party):
Ji-youn Han, National Cancer Center, Korea

Brief Summary:
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, the investigators 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Irinotecan, Cisplatin, Gemcitabine, Pemetrexed, Docetaxel Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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;
Study Start Date : February 2009
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: ERCC1 negative - GP
Gemcitabine (1250 mg/m2) IV on D 1, 8. Cisplatin (75 mg/m2) IV on D1 every 3 weeks.
Drug: Irinotecan, Cisplatin, Gemcitabine, Pemetrexed, Docetaxel

GP:

Gemcitabine (1250 mg/m2) IV on day1, 8. Cisplatin (75 mg/m2) IV on day1 every 3 weeks

IP:

Irinotecan (65 mg/m2) IV on day 1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks

2nd or 3rd: Pemetrexed (500 mg/m2) D1 with premedication every 3 weeks Docetaxel (75 mg/m2) D1 with premedication every 3 weeks

Other Name: Campto

Experimental: ERCC1 positive - IP
Irinotecan (65 mg/m2) IV on day1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks
Drug: Irinotecan, Cisplatin, Gemcitabine, Pemetrexed, Docetaxel

GP:

Gemcitabine (1250 mg/m2) IV on day1, 8. Cisplatin (75 mg/m2) IV on day1 every 3 weeks

IP:

Irinotecan (65 mg/m2) IV on day 1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks

2nd or 3rd: Pemetrexed (500 mg/m2) D1 with premedication every 3 weeks Docetaxel (75 mg/m2) D1 with premedication every 3 weeks

Other Name: Campto

Experimental: ERCC1 positive - GP
Gemcitabine (1250 mg/m2) IV on day1, 8 Cisplatin (75 mg/m2) IV on day1 every 3 weeks
Drug: Irinotecan, Cisplatin, Gemcitabine, Pemetrexed, Docetaxel

GP:

Gemcitabine (1250 mg/m2) IV on day1, 8. Cisplatin (75 mg/m2) IV on day1 every 3 weeks

IP:

Irinotecan (65 mg/m2) IV on day 1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks

2nd or 3rd: Pemetrexed (500 mg/m2) D1 with premedication every 3 weeks Docetaxel (75 mg/m2) D1 with premedication every 3 weeks

Other Name: Campto

Experimental: ERCC1 negative - IP
Irinotecan (65 mg/m2) IV on day1, 8 Cisplatin (30 mg/m2) IV on day 1, 8 every 3 weeks
Drug: Irinotecan, Cisplatin, Gemcitabine, Pemetrexed, Docetaxel

GP:

Gemcitabine (1250 mg/m2) IV on day1, 8. Cisplatin (75 mg/m2) IV on day1 every 3 weeks

IP:

Irinotecan (65 mg/m2) IV on day 1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks

2nd or 3rd: Pemetrexed (500 mg/m2) D1 with premedication every 3 weeks Docetaxel (75 mg/m2) D1 with premedication every 3 weeks

Other Name: Campto




Primary Outcome Measures :
  1. Response Rate [ Time Frame: every 6 weeks ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: every 8 weeks ]
    from the first day of treatment to death

  2. Progression-free survival (PFS) [ Time Frame: every 6 weeeks ]
    as the period between the day of the treatment and the date of progression or death

  3. Toxicity [ Time Frame: every 3 weeks ]
    from C1D1 to 30 days after the last dose administration

  4. Pharmacogenomic study using tumor tissue and blood for providing rational strategy to the treatment of advanced NSCLC [ Time Frame: 2 times ]
    at baseline and time to disease progression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003964


Locations
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Korea, Republic of
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: JI-YOUN HAN, M.D. National Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ji-youn Han, Head, Center for Lung Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01003964    
Other Study ID Numbers: NCCCTS-08-371
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013
Keywords provided by Ji-youn Han, National Cancer Center, Korea:
NON-SMALL CELL LUNG CANCER
excision repair cross-complementing 1
Gemcitabine and cisplatin
Irinotecan and cisplatin
Pemetrexed
Docetaxel
advanced NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Docetaxel
Irinotecan
Pemetrexed
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Folic Acid Antagonists