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http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=360622&version=patient&protocolsearchid=1026401
Summary
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.
Eligibility
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.
Disclaimer
Information about this trial is from the ClinicalTrials.gov
database. The versions designated for health professionals and
patients contain the same text. Minor changes may be made to the
ClinicalTrials.gov record to standardize the names of study
sponsors, sites, and contacts. Cancer.gov only lists sites that are
recruiting patients for active trials, whereas ClinicalTrials.gov
lists all sites for all trials. Questions and comments regarding
the presented information should be directed to ClinicalTrials.gov.
Trial Sites and
Contacts
Arkansas
Springdale
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.
California
Torrance
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.
*** POSTED ON MARCH 5, 2004 ***
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