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Paclitaxel Detection in NSCLC Treated With TC Regimen

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ClinicalTrials.gov Identifier: NCT02737709
Recruitment Status : Terminated (The study have difficulty in recruiting subjectes)
First Posted : April 14, 2016
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Li Zhang, MD, Sun Yat-sen University

Brief Summary:

By detecting the blood concentration of paclitaxel (PTX), Investigator assume this research can identify the individual differences of PTX pharmacokinetics (PK) parameters (TC>0.05 refers to the duration of paclitaxel plasma concentration above 0.05 µmol/L) in Chinese non-small cell lung cancer (NSCLC) patients, and find the correlation between PK results and PTX toxicities and Effectiveness, acquire the optimization method of PTX, and finally try to explore the individualized PTX pharmacokinetically-guided dosing strategy. Orally administer rosiglitazone, which is a substrate of CYP2C8 the same as paclitaxel, before chemotherapy injection. Detect the blood concentration of rosiglitazone, analyze the correlation of rosiglitazone pharmacokinetic parameter and paclitaxel exposure, and explore the effect of rosiglitazone as an in vivo probe of paclitaxel exposure.

  1. The variability of paclitaxel concentrations in the patient population dosed by body surface area (BSA), and the limitation of BSA-based dosing of paclitaxel.
  2. Verify that paclitaxel TC>0.05 is the most relevant predictor of haematological toxicity and clinical outcomes.
  3. Define a dosing algorithm based on paclitaxel TC>0.05 of paclitaxel and quantify its effect on both reducing toxicity and improving Effectiveness.
  4. The effect of using dose modification and administration of G-CSF based on toxicity determined by paclitaxel TC>0.05 measurement.
  5. Construct a trial outline with the aim of reducing grade 4 neutropenia toxicity and ensuring the clinical outcome by using individual dose adjustments based on the dosing algorithm.
  6. Detect the blood concentration of rosiglitazone after orally administration, explore the effect of rosiglitazone as an in vivo probe of paclitaxel exposure based on CYP2C8 activity. Attempt to establish a model to predict the paclitaxel exposure of patients base on rosiglitazone blood concentration before chemotherapy.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Paclitaxel and Carboplatin regimen Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Experience Trial to Detect the Plasma Paclitaxel Drug Concentration in Chinese Non -Small Cell Lung Cancer (NSCLC) Patients Treated With a Paclitaxel Plus Carboplatin (TC) Regimens, and Explore Individualized Treatment Using Pharmacokinetically-guided Dosing Strategy
Study Start Date : March 2016
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Paclitaxel and Carboplatin regimen
Paclitaxel: 175mg/m2, d1; Intravenous drip injection with 500ml N.S Carboplatin: AUC=5, d1; Intravenous drip injection with 500ml G.S Paclitaxel injection at first, followed with Carboplatin injection. 21 days per cycle; 6 cycles in total.
Drug: Paclitaxel and Carboplatin regimen
Chemotherapy regimen:Paclitaxel: 175mg/m2, d1; Intravenous drip injection with 500ml N.S;Carboplatin: AUC=5, d1; Intravenous drip injection with 500ml G.S Paclitaxel injection at first, followed with Carboplatin injection.
Other Name: treatment group




Primary Outcome Measures :
  1. Change of tumor sizes from baseline [ Time Frame: baseline; 6 weeks; 12 weeks; 18 weeks; 24 weeks; 32 weeks; up to 3 years. ]
    Object response rate (ORR): assess the ORR of paclitaxel/carboplatin chemotherapy according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of rosiglitazone [ Time Frame: 3 hours after rosiglitazone administration ]
    Detect the plasma concentration of rosiglitazone 3 hours after orally administration of rosiglitazone.

  2. The duration of paclitaxel plasma concentration above 0.05 µmol/L (TC>0.05) [ Time Frame: 5min before paclitaxel administration; and 24 hours after. ]
    Detect the blood concentration of paclitaxel 24 hours after the initiation, Calculate paclitaxel TC>0.05

  3. Toxicities rate [ Time Frame: day10, day21, day 31, day 42, day 52, day 63, day 73, day 84, day 94, day 105, day115 and day 126. ]
    Toxicities rate: assess the toxicities rate and severity of paclitaxel/carboplatin chemotherapy according to Common Terminology Criteria For Adverse Events (CTCAE) v4.03, and analyze the relationship of paclitaxel TC>0.05 and toxicities.

  4. progression free survival (months) [ Time Frame: From date of consent form until the date of first documented progression, up to 36 months. ]
    Survival Effectiveness: assess the progression free survival (PFS) of paclitaxel/carboplatin chemotherapy

  5. Overall survival (months) [ Time Frame: From date of consent form until the date of death from any cause, up to 36 months. ]
    Survival Effectiveness: assess the overall survival (OS) of paclitaxel/carboplatin chemotherapy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 ~75 years
  • Pathology: Confirmed by pathology (histology or cytology) for advanced non-small cell lung cancer
  • Have indications of paclitaxel/carboplatin chemotherapy, suitable for paclitaxel chemotherapy (independent of clinical tumor stage or chemotherapy type or palliative chemotherapy lines)
  • At least one measurable tumor lesions (according to RECIST 1.1 criteria)
  • ECOG PS score: 0 to 2 points
  • Life expectancy: more than 3 months
  • Bone marrow reserve function is good, the function of organs (liver and kidney) is good, can satisfy the conditions of implementation chemotherapy. neutrophil count ≥1.5×109/l, platelet ≥75×109/l, hemoglobin >9g/dl, Total Bilirubin ≤1.5×ULN*, transaminase <2.5×ULN*, creatinine ≤1.5×ULN*,or creatinine clearance rate ≥45ml/min. ULR: Upper Limit Of Normal.
  • Sign the informed consent form; Compliance is good, can be followed up, willing to comply with the requirements of the study

Exclusion Criteria:

  • ECOG Performance Scores > 2 points
  • Organic disease (heart, liver, kidney disease etc), Active infection Organ transplantation immunosuppressive therapy, not capable to complete 4 - 6 cycles of paclitaxel / carboplatin chemotherapy.
  • Any other tumor history not cured in 3 years before this trial.
  • Bone marrow function or organs function not eligible for chemotherapy.
  • Diabetic patients currently receiving the standard anti- diabetes treatment.

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): NCT02737709


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Li Zhang, M.D. Sun Yat-sen University

Publications:

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Responsible Party: Li Zhang, MD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02737709     History of Changes
Other Study ID Numbers: CA139-703
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action