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Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00846443
Recruitment Status : Unknown
Verified February 2009 by Fudan University.
Recruitment status was:  Recruiting
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
Fudan University

Study Description
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Brief Summary:
The purpose of this study is to determine the recommended dose of pemetrexed and the maximum tolerated dose of radiotherapy when using concurrent pemetrexed/cisplatin/radiotherapy in the patients with local advanced non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Local Advanced Non-Small Cell Lung Cancer Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy Phase 1

Detailed Description:
This study was conducted to explore the feasibility of concurrent chemoradiation therapy with pemetrexed, cisplatin and radiotherapy in unresectable local advanced non-small cell lung cancer. We will perform the dose escalation of pemetrexed to determine if full dose (500mg/m2) of pemetrexed could be administrated concurrently with cisplatin and conventional dose radiotherapy (66Gy) firstly. Secondly, radiation dose will be escalated to determine the maximum tolerated dose (MTD) of radiotherapy when administered concurrently with full dose pemetrexed and cisplatin.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer.
Study Start Date : January 2009
Estimated Primary Completion Date : January 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
pemetrexed:400 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
 Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
pemetrexed:400 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
Experimental: 2
pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
 Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
Experimental: 3
pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:70 Gy in 35 fractions
 Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:70 Gy in 35 fractions
Experimental: 4
pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:74 Gy in 37 fractions
 Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:74 Gy in 37 fractions


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicities per protocol [ Time Frame: every 3 months from the end of treatment to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≧18 years.
  • Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Patients with histologically or cytological-proven non-small cell lung cancer.
  • Stage IIIA or IIIB, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
  • Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
  • Weight loss ≦ 5% in the previous six months.
  • Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
  • Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

  • Undifferentiated small cell carcinoma, any stage.
  • Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
  • Stage IV.
  • Age <18 years.
  • Performance status ≧2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Previous chemotherapy or previous biologic response modifiers for current lung cancer.
  • Patient has previously had thoracic radiation therapy.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
  • Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
  • History of significant neurological or mental disorder, including seizures or dementia.
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (e.g. naproxen, piroxicam, diflusinal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed.
  • Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
  • Pregnant or lactating females.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00846443


Contacts
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Contact: Xiaolong Fu, MD 862164175590 ext 1408 xlfu1964@126.com
Contact: Zhengfei Zhu, MD 862164175590 ext 1404 zfeizhu@yahoo.com.cn

Locations
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China, Shanghai
Department of Radiation Oncolory, Cancer Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Liang Xiahou, MB    862164175590 ext 1404    xiahouliang@hotmail.com   
Principal Investigator: Xiaolong Fu, MD         
Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: Xiaolong Fu, Cancer Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00846443    
Other Study ID Numbers: NSCLC2009
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009
Keywords provided by Fudan University:
non-small cell lung cancer
Additional relevant MeSH terms:
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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
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors