A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients
This study has been completed.
Sponsor:
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01531790
First received: February 7, 2012
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Carboplatin Drug: Pemetrexed Drug: Endostar Drug: Centrum |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:
Primary Outcome Measures:
- Dose Limiting Toxicity [ Time Frame: up to 21 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Objective Response Rate [ Time Frame: up to 6 cycles ] [ Designated as safety issue: No ]
- Disease Control Rate [ Time Frame: up to 6 cycles ] [ Designated as safety issue: No ]
- Progression-free Survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 19 |
| Study Start Date: | September 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Endostar plus pemetrexed/carboplatin
21 days as one cycle, for a total of 4-6 cycles
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531790
Locations
| China, Guangdong | |
| Sun Yat-sen University Cancer Center | |
| Guangzhou, Guangdong, China | |
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Investigators
| Principal Investigator: | Li Zhang, MD | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | Jiangsu Simcere Pharmaceutical R&D Co. Ltd. |
| ClinicalTrials.gov Identifier: | NCT01531790 History of Changes |
| Other Study ID Numbers: | SIM-93 |
| Study First Received: | February 7, 2012 |
| Last Updated: | January 15, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:
|
Endostar Carboplatin Pemetrexed NSCLC Phase I |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Pemetrexed Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 16, 2013