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Alimta (pemetrexed) in Patients with Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy



Alimta (pemetrexed) in Patients with Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy

For Condition: Non-Small-Cell Lung Carcinoma
Status: Recruiting
Sponsor(s): Eli Lilly and Company ,
Synopsis: The purposes of this study are to determine: - the safety of ALIMTA and any side effects that might be associated with it - how much ALIMTA should be given to patients. It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate ALIMTA for other possible uses or for other medical or scientific purposes other than those currently proposed. Although ALIMTA has been shown to be effective in some patients with non-small-cell lung cancer, ALIMTA might not have beneficial effects for all patients.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy. - Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence. - No more than two prior systemic anti-cancer therapies will be allowed. - Prior radiation therapy is allowed to <25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment. Exclusion Criteria: - Pregnancy. - Breast-feeding. - Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. - Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period. - Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Total Enrollment: 1000

Location and Contact Information:

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. *Recruiting*
Springdale,  Arkansas, 
United States
Recruiting  

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. *Recruiting*
Torrance,  California, 
United States
Recruiting  


Additional Information:
Study ID Numbers:
  8433; 
Study Start Date: 
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078260

Other Non-Small-Cell Lung Carcinoma Studies:
1. Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Non-Small Cell Lung Cancer

2. p53 Peptide Vaccination to Treat Lung Cancer

3. Alimta (pemetrexed) in Patients with Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy

4. Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion in Patients with Pulmonary and Pleural Malignancies

5. Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

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Alimta (pemetrexed) in Patients with Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy

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