The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01564329
First received: March 21, 2012
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

To evaluate the change of blood perfusion before/after the use of Endostar, discuss the time sequence of Endostar TM in treating advanced lung adenocarcinoma in normalization window period.


Condition Intervention Phase
Advanced Primary Lung Adenocarcinoma
Drug: endostar
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar

Resource links provided by NLM:


Further study details as provided by Simcere Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • the change of blood perfusion before/after the use of Endostar [ Time Frame: per 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tumor to progress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    tumor to progress

  • clinical benefit rate [ Time Frame: per 6 weeks ] [ Designated as safety issue: No ]
  • Adverse Drug Reaction [ Time Frame: per 1 day ] [ Designated as safety issue: Yes ]
    NCI-CTCAE V3.0


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: endostar2
CT Perfusion Imaging(CTPI) at D0, D21 of the first cycle、D6, D14 of the second cycle, measure blood flow ( BF ), blood volume ( BV ), mean transit time ( MTT ), start time ( TTS ), time to peak ( TTP ), Patlak blood volume ( pBV ), vascular permeability etc. before/after tumor tissue treatment.
Drug: endostar
Endostar TM 7.5mg/m2,intravenous drip, Day 1to Day 10;Pemetrexed 500mg/m2, intravenous drip, Day 6; Carboplatin AUC=5,intravenous drip, Day 6; 21 days as a cycle, 4 cycles in all.
Experimental: endostar1
CT Perfusion Imaging(CTPI) at D0,D6, D14, D21 of the first period, measure blood flow ( BF ), blood volume ( BV ), mean transit time ( MTT ), start time ( TTS ), time to peak ( TTP ), Patlak blood volume ( pBV ), vascular permeability etc. before/after tumor tissue treatment.
Drug: endostar
Endostar TM 7.5mg/m2,intravenous drip, Day 1to Day 10;Pemetrexed 500mg/m2, intravenous drip, Day 6; Carboplatin AUC=5,intravenous drip, Day 6; 21 days as a cycle, 4 cycles in all.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically newly diagnosed as unresectable and metastasis advanced lung adenocarcinoma(Stage IV, Seventh Edition of the UICC/AJCC Classification for Lung Cancer).
  • At least one measurable objective tumor lesion, spiral CT or PET-CT examination: the shortest diameter ≥2cm,and no obvious necrosis
  • Life expectancy ≥12weeks
  • Patients receive palliative radiotherapy for bone's pain relief; patients receive radiotherapy for brain metastasis、patients after brain transfer operation or radiation therapy are allowed to enter the research.
  • 18≤Patients'age <70 years.
  • Electrocolonogram (ECOG) Score:0-1.
  • Granulocyte count ≥ 2.0×109/L, platelet count ≥ 100×109/L.
  • Serum bilirubin within the normal range.
  • Aspartate aminotransferase ( AST ), Alanine aminotransferase ( ALT ) within the normal range(if the patients is diagonosed as liver metastasis,his/her AST/ALT should not surpass 1.5 times of the normal range ).
  • Serum creatinine within the normal range and creatinine clearance rate ≥60ml/min
  • Compliance with research requirements and be able to follow up.
  • Within 72 hours before the treatment, all women pregnant with pregnant possibility should undergo pregnancy test and get negative results.
  • Patients with fertility ability should take effective contraceptive techniques.
  • Sign informed consent of this clinic trial.

Exclusion Criteria:

  • Lung adenocarcinoma patients who received systemic chemotherapy/thoracic radiotherapy/targeted therapy
  • Received resection, cutting or aspiration within seven days
  • Any unstable systemic diseases (including peptic ulcer、active infection、grade4 hypertension、unstable angina、congestive heart failure、liver, metabolic disorders or fracture、unhealing wound )
  • Chronic kidney disease history(including chronic nephritis, nephrotic syndrome, Obstruction of urinary tract etc. caused by Urinary calculus)
  • have to use anticoagulant drugs at the same time
  • patients with obvious coagulation disorders、active bleeding and bleeding tendency
  • Any other malignancies (complete cure of cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma are excluded )happened within 5 years.
  • Signifinant weight loss, weight lost during the 6 weeks more than or equal to 10%
  • Patients who take bone metastasis as the only observing index
  • Allergic to escherichia coli preparation
  • Used Endostar before
  • Lactating women
  • Contraindications written on Pemetrexed、Carboplatin、Dexamethasone instructions
  • Allergic to radiographic contrast agents
  • In the middle or planning to attend other clinic trails
  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: NCT01564329

Contacts
Contact: You Lu, MD 86-028-85422114 radyoulu@hotmail.com
Contact: Meijuan Huang, MD 86-028-85422114 hmj107@163.com

Locations
China, Sichuan
The Department of Thoracic Oncology in West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Meijuan Huang, MD         
Contact: You Lu, MD         
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01564329     History of Changes
Other Study ID Numbers: sim-endo-201201
Study First Received: March 21, 2012
Last Updated: March 23, 2012
Health Authority: China: Ethics Committee

Keywords provided by Simcere Pharmaceutical Co., Ltd:
endostar
CT Perfusion
Advanced Primary Lung Adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014