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Open-Label Single-Arm Phase 2 Study of ALIMTA in Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small Cell Lung

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Trial Information

Open-Label Single-Arm Phase 2 Study of ALIMTA in Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy


Inclusion Criteria:



- diagnosis of NSCLC

- Locally advanced or metastatic disease (Stage IIIB or IV).

- Patients must have previously received one chemotherapy regimen for palliative
therapy of locally advanced or metastatic disease.

- Disease status must be that of measurable disease as defined by RECIST criteria

- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale;
and adequate organ function.

Exclusion Criteria:

- Known or suspected brain metastasis, or Second primary malignancy that is clinically
detectable at the time of consideration for study enrollment

- Concurrent administration of any other tumor therapy.

- History of significant neurological or mental disorder, including seizures or
dementia; or any other serious concomitant disorders that would compromise the safety
of the patient or compromise the patient's ability to complete the study

- 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.

- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or
dexamethasone

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate according to RECIST criteria

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

6685

NCT ID:

NCT00190840

Start Date:

September 2003

Completion Date:

October 2005

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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