Detect the Plasma Drug Concentration of Docetaxel and Paclitaxel, and Explore the Pharmacokinetically-guided Dosing Strategy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01891123
First received: June 18, 2013
Last updated: August 10, 2013
Last verified: August 2013
  Purpose

This is a clinical experience trial, using the rapid plasma drug concentration detection kit to detect the plasma drug concentration of docetaxel and paclitaxel in Chinese lung cancer patients and breast cancer patients. To assess the statistical difference of PTX/DOC plasma drug concentration using traditional body surface area method, and to evaluate the correlation between plasma drug concentration and clinical toxicity or clinical effect, at last, achieve the personalized treatment according to the plasma drug concentration


Condition Intervention
Non-small Cell Lung Cancer
Breast Cancer
Device: Detection Kit
Drug: PTX 175mg/m2, DOC 75mg/m2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Experience Trial Using Rapid Plasma Drug Concentration Detection Kit in Chinese Lung Cancer and Breast Patients Treated With a Paclitaxel or Docetaxel-based Regimens, and Explore the Pharmacokinetically-guided Dosing Strategy

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The objective response rate [ Time Frame: up to 18 weeks ] [ Designated as safety issue: Yes ]
    participants will be evaluated for response of treatment after 2 cycles,4 cycles and 6 cycles. 3weeks per cycle, so the expected time frame will be 6/12/18 weeks


Secondary Outcome Measures:
  • progression free survival; overall survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence and severity of adverse reactions [ Time Frame: 3 weeks, 6 weeks, 9 weeks, 12 weeks, 15 weeks, 18weeks ] [ Designated as safety issue: Yes ]
    participants will be evaluated for adverse reactions of treatment every cycle. 3 weeks per cycle, so the expected time frame will be 3/6/9/12/15/18 weeks


Other Outcome Measures:
  • the quality of life of patients [ Time Frame: 3 weeks, 6 weeks, 9 weeks, 12 weeks, 15 weeks, 18weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: body surface area
patients receive PTX or DOC dose based on body surface area every cycle, PTX 175mg/m2, DOC 75mg/m2. Patients should finish at least 4 cycles chemotherapy
Drug: PTX 175mg/m2, DOC 75mg/m2
patients receive PTX or DOC dose based on body surface area every cycle, PTX 175mg/m2, DOC 75mg/m2
Active Comparator: Detection Kit
PTX 175mg/m2, DOC 75mg/m2 at first cycle. the dose of PTX or DOC will adjust based on the plasma drug concentration of previous cycle. A target interval of PTX and DOC have been set before the trial based on earlier studies of the drugs. at least 4 cycles
Device: Detection Kit
the dose of PTX or DOC will adjust based on the plasma drug concentration of previous cycle
Other Name: Rapid Plasma Drug Concentration Detection Kit

Detailed Description:

Lung cancer patients receive a paclitaxel and carboplatin doublet regimen, lung cancer and breast cancer patients receive a docetaxel single-agent regimen chemotherapy are included in this clinical experience trial. So this trial consists of three sub-trials: PTX in lung cancer, Doc in lung cancer and Doc in lung cancer. Patients are randomly assigned into the BSA-based dosing group and the concentration-based dosing group. In the BSA-based dosing group, patients receive PTX or DOC dose based on body surface area every cycle, PTX 175mg/m2, DOC 75mg/m2. The dose will adjust according to the China Great Pharmacopoeia only when the adverse reaction occurs. In the concentration-based dosing group, the dose of PTX or DOC will adjust based on the plasma drug concentration of previous cycle. A target interval of PTX and DOC have been set before the trial based on earlier studies of the drugs. Patients should finish at least 4 cycles chemotherapy, treatment should continue until disease progression or unacceptable toxicity occurs. Toxicity assessment is conducted every cycle.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed by pathology for advanced lung cancer, suitable for paclitaxel or docetaxel chemotherapy (independent of clinical stage or chemotherapy type)
  • At least one measurable lesions (according to RECIST criteria)
  • ECOG PS score: 0 to 2 points
  • Survival is expected to more than 3 month
  • Bone marrow reserve function is good, the function of organs (liver and kidney) is good, can satisfy the conditions of implementation chemotherapy.
  • Sign the informed consent form
  • Compliance is good, can be followed up, willing to comply with the requirements of the study

Exclusion Criteria:

  • Physical status score (ECOG) greater than 2
  • organic disease;Severely active infection;Organ transplantation immune therapy;Can't complete with in four to six cycles of chemotherapy
  • Bone marrow, liver and kidney dysfunction, clinical doctors identify intolerance to chemotherapy
  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: NCT01891123

Contacts
Contact: YuXiang Ma 86-020-87343786 mayx@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
GuangZhou, Guangdong, China, 510030
Contact: YuXiang Ma    8602087343786    mayx@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Li Zhang Sun Yat-sen University
Principal Investigator: Shu Sen Wang Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Li Zhang, Profressor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01891123     History of Changes
Other Study ID Numbers: DT0508
Study First Received: June 18, 2013
Last Updated: August 10, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Non-small Cell Lung Cancer
Breast cancer
plasma drug concentration

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carcinoma, Non-Small-Cell Lung
Skin Diseases
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Docetaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014