Personalized Therapy in Non-small Cell Lung Cancer - Full Text View

Purpose

Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) 、β-tubulin (TUB) and thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to platinum agents 、paclitaxel gemcitabine and pemetrexed respectively.

Tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial. Here, we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the "personalized therapy" approach versus other standard approaches.

Condition	Intervention	Phase
Lung Cancer Carboplatin Adverse Reaction	Drug: carboplatin, gemcitabine,pemetrexed,docetaxel	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS/β-Tubulin Expression

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Gemcitabine Docetaxel Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Guangzhou Medical University:

Primary Outcome Measures:

progression-free survival of Patients [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
From treatment beginning,Patients will be followed for up to 2 years.

Secondary Outcome Measures:

disease-free survival of patients [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
After treatment beginning, patients will be followed for up to 5 years.

Other Outcome Measures:

overall survival of patients [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
From treatment beginning, the patients will be followed for up to 5 years.

Estimated Enrollment:	200
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A.Individuation chemotherapy for A.Individuation chemotherapy The patients received the chemotherapy regimens based on ERCC1, RRM1, TS and β-tubulin expression measured by immunohistochemical staining. Patients received carboplatin at AUC=5, gemcitabine 1250 mg/m2 on days 1 and 8, or pemetrexed 500mg/m2, or docetaxel 75 mg/m2 in each 21 day cycle.	Drug: carboplatin, gemcitabine,pemetrexed,docetaxel Drugs are chosen to be used in the both Arms carboplatin: iv on the first day of each cycle until PD or unacceptable toxicity or no more than 6 cycles gemcitabine :500 mg/m² intravenous (iv) on the first and eighth days of each 21day cycle pemetrexed :1250 mg/m² intravenous (iv) on the first day of each cycle until PD or unacceptable toxicity or no more than 6 cycles docetaxel:75 mg/m² intravenous (iv) on the first day of each cycle Other Names: Drug: carboplatin Other Names:platinum Drug: gemcitabine Drug: pemetrexed Other Names:ALIMTA
Experimental: B. standard therapy carboplatin non-individuation and chemotherapy	Drug: carboplatin, gemcitabine,pemetrexed,docetaxel Drugs are chosen to be used in the both Arms carboplatin: iv on the first day of each cycle until PD or unacceptable toxicity or no more than 6 cycles gemcitabine :500 mg/m² intravenous (iv) on the first and eighth days of each 21day cycle pemetrexed :1250 mg/m² intravenous (iv) on the first day of each cycle until PD or unacceptable toxicity or no more than 6 cycles docetaxel:75 mg/m² intravenous (iv) on the first day of each cycle Other Names: Drug: carboplatin Other Names:platinum Drug: gemcitabine Drug: pemetrexed Other Names:ALIMTA

Arms

Assigned Interventions

Experimental: A.Individuation chemotherapy

for A.Individuation chemotherapy The patients received the chemotherapy regimens based on ERCC1, RRM1, TS and β-tubulin expression measured by immunohistochemical staining.

Patients received carboplatin at AUC=5, gemcitabine 1250 mg/m2 on days 1 and 8, or pemetrexed 500mg/m2, or docetaxel 75 mg/m2 in each 21 day cycle.

Drug: carboplatin, gemcitabine,pemetrexed,docetaxel

Drugs are chosen to be used in the both Arms carboplatin: iv on the first day of each cycle until PD or unacceptable toxicity or no more than 6 cycles gemcitabine :500 mg/m² intravenous (iv) on the first and eighth days of each 21day cycle pemetrexed :1250 mg/m² intravenous (iv) on the first day of each cycle until PD or unacceptable toxicity or no more than 6 cycles docetaxel:75 mg/m² intravenous (iv) on the first day of each cycle

Other Names:

Drug: carboplatin
Other Names:platinum
Drug: gemcitabine
Drug: pemetrexed
Other Names:ALIMTA

Experimental: B. standard therapy

carboplatin non-individuation and chemotherapy

Drug: carboplatin, gemcitabine,pemetrexed,docetaxel

Drugs are chosen to be used in the both Arms carboplatin: iv on the first day of each cycle until PD or unacceptable toxicity or no more than 6 cycles gemcitabine :500 mg/m² intravenous (iv) on the first and eighth days of each 21day cycle pemetrexed :1250 mg/m² intravenous (iv) on the first day of each cycle until PD or unacceptable toxicity or no more than 6 cycles docetaxel:75 mg/m² intravenous (iv) on the first day of each cycle

Other Names:

Drug: carboplatin
Other Names:platinum
Drug: gemcitabine
Drug: pemetrexed
Other Names:ALIMTA

Detailed Description:

Patients who had nonsmall cell lung cancer (NSCLC) performance status of 0/1 were accrued to 2 phase 2 clinical trials Trial A (carboplatin and chemotherapy individuation based on sensitivity marker ), Trial B (carboplatin non-individuation or chemotherapy non-individuation ).

Patients who were treated on Trials B were analyzed as the "standard therapy" group. Patients accrued to Trial A were called the "personalized therapy" group. Overall survival (OS), disease free survival (DFS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological or cytological diagnosis of lung adenocarcinoma histology,
age from 18 years to 75 years
ECOG Performance Status no more than 2
at least one appraisable lung focus of diameter≥ 10 mm by lung CT
Haemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥(ANC) 1.5 x 109/L, platelets ≥100 x 109/L
Total bilirubin ≤1.5 x upper limit of normal (ULN)
ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula)

Exclusion Criteria:

Mixed non-adenocarcinoma cell lung cancer histology
Previous treatment for Systemic chemotherapy or local radiotherapy
Be allergic to chemotherapy drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781988

Contacts

Contact: Yuwen He, Dr

08615920105562

heyuwen82@126.com

Locations

China, Guangdong
The first affiliated hospital of Guangzhou MC	Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yuwen He, Dr heyuwen82@126.com
Principal Investigator: Yuwen He, Dr.

Sponsors and Collaborators

Guangzhou Medical University

The First Affiliated Hospital of Guangzhou Medical University

Investigators

Study Chair:

Jianxing He, Proressor

The first affiliated hospital of Guangzhou MC

More Information

No publications provided

Responsible Party:	Heyuwen, Yuwen He, MD, Guangzhou Medical University
ClinicalTrials.gov Identifier:	NCT01781988 History of Changes
Other Study ID Numbers:	GZMC12521, PT12521
Study First Received:	January 24, 2013
Last Updated:	March 15, 2013
Health Authority:	United States: Food and Drug Administration China: Food and Drug Administration

Keywords provided by Guangzhou Medical University:

lung cancer
gemcitabine
carboplatin
pemetrexed

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Pemetrexed
Docetaxel
Carboplatin

Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on May 23, 2013

Personalized Therapy in Non-small Cell Lung Cancer (PTINCLC)