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

NCT01564329 | Unknown Phase 2 DMC

• 1 other identifier: sim-endo-201201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Primary Lung Adenocarcinoma

Keywords

endostar; CT Perfusion; Advanced Primary Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• the change of blood perfusion before/after the use of Endostar

  per 3 weeks

Secondary Outcomes (3)

• tumor to progress

  6 months

• clinical benefit rate

  per 6 weeks

• Adverse Drug Reaction

  per 1 day

Study Arms (2)

endostar2

EXPERIMENTAL

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

endostar1

EXPERIMENTAL

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

Interventions

endostar DRUG

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.

endostar1; endostar2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ≤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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead

Study Sites (1)

The Department of Thoracic Oncology in West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Interventions

endostar protein

Central Study Contacts

You Lu, MD

CONTACT

86-028-85422114; radyoulu@hotmail.com

Meijuan Huang, MD

CONTACT

86-028-85422114; hmj107@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 27, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 27, 2012

Record last verified: 2012-03

Locations

CN (1)