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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The First Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Heyuwen, Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01781988
First received: January 24, 2013
Last updated: March 24, 2014
Last verified: March 2014
  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:


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 4 years ] [ Designated as safety issue: Yes ]
    After treatment beginning, patients will be followed for up to 4 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: June 2015
Estimated Primary Completion Date: December 2014 (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(area under curve )=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 progressive disease 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 progressive disease 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 to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed non-small cell lung cancer
  2. age from 18 years to 75 years
  3. ECOG Performance Status no more than 2
  4. at least one appraisable lung focus of diameter≥ 10 mm by lung CT
  5. Haemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥(ANC) 1.5 x 109/L, platelets ≥100 x 109/L
  6. Total bilirubin ≤1.5 x upper limit of normal (ULN)
  7. ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
  8. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula)
  9. Informed consent should be obtained before treatment.

Exclusion Criteria:

  1. Mixed non-adenocarcinoma cell lung cancer histology
  2. Previous treatment for Systemic chemotherapy or local radiotherapy
  3. Be allergic to chemotherapy drugs
  4. second active primary malignancy or serious concomitant medical disease
  5. difficulties with adequate follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China, Guangdong
The first affiliated hospital of Guangzhou MC
Guangzhou, Guangdong, China, 510120
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 24, 2014
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:
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
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on October 19, 2014