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

Phase 1
18 Years
Open (Enrolling)
Local Advanced Non-Small Cell Lung Cancer

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Trial Information

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

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.

Inclusion Criteria:

- Age ≧18 years.

- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG)

- 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

- 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

- History of significant neurological or mental disorder, including seizures or

- 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

- Pregnant or lactating females.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicities per protocol

Outcome Time Frame:

every 3 months from the end of treatment to 2 years

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Local Advanced Non-Small Cell Lung Cancer
  • non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms