A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients
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ClinicalTrials.gov Identifier: NCT01531790 |
Recruitment Status :
Completed
First Posted : February 13, 2012
Last Update Posted : January 16, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: Carboplatin Drug: Pemetrexed Drug: Endostar Drug: Centrum | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Endostar plus pemetrexed/carboplatin
21 days as one cycle, for a total of 4-6 cycles
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Drug: Carboplatin
d1, AUC 5, i.v. Drug: Pemetrexed d1, 500 mg/m2, i.v. Drug: Endostar d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc. Drug: Centrum 1 tablet/day |
- Dose Limiting Toxicity [ Time Frame: up to 21 days ]
- Objective Response Rate [ Time Frame: up to 6 cycles ]
- Disease Control Rate [ Time Frame: up to 6 cycles ]
- Progression-free Survival [ Time Frame: up to 2 years ]
- Overall Survival [ Time Frame: up to 2 years ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC
- At least one measurable lesion (RECIST criteria)
- Life expectancy > 3 months
- ECOG performance status 0-2
- Adequate hematologic function: WBC ≥ 3.0×109 /L,ANC ≥ 1.5×109 /L,Hb ≥ 90 g/L,PLT ≥ 100×109 /L
- Adequate renal, hepatic and coagulation function
- Written informed consent
Exclusion Criteria:
- With uncontrollable malignant pleural effusion or ascites
- Thoracic or abdominal surgery within 28 days prior to study entry
- History of cerebral stroke or TIA within 6 months prior to study entry
- With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy
- Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (> NYHA class II)
- With serious infection (> NCI CTC grade 2)
- Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry
- Symptomatic brain metastases
- Patient who has epilepsy
- History of HIV infection or chronic hepatitis B or C
- Allergic to any of the study drugs
- Pregnant or lactating women

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): NCT01531790
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China |
Principal Investigator: | Li Zhang, MD | Sun Yat-sen University |
Responsible Party: | Jiangsu Simcere Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01531790 |
Other Study ID Numbers: |
SIM-93 |
First Posted: | February 13, 2012 Key Record Dates |
Last Update Posted: | January 16, 2013 |
Last Verified: | January 2013 |
Endostar Carboplatin Pemetrexed NSCLC Phase I |
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 Carboplatin Pemetrexed |
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