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

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
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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 |
- Dose-limiting toxicities per protocol [ Time Frame: every 3 months from the end of treatment to 2 years ]

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

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
Contact: Xiaolong Fu, MD | 862164175590 ext 1408 | xlfu1964@126.com | |
Contact: Zhengfei Zhu, MD | 862164175590 ext 1404 | zfeizhu@yahoo.com.cn |
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 |
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 |
non-small cell lung cancer |
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 |