| April 18, 2006 |
| March 26, 2009 |
| December 2006 |
| March 2009 (final data collection date for primary outcome measure) |
| Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ] |
- This study will evaluate the safety and pharmacokinetics of pemetrexed in patients with third-space fluid. This outcome will be fully evaluated once the last patient receiving study treatment has discontinued from study treatment.
- Secondary: This study will identify increases in the toxicity of pemetrexed, assess the clinical relevance of any alterations in pemetrexed pharmacokinetics and provide pemetrexed dosing recommendations, in patients with third-space fluid.
|
| Complete list of historical versions of study NCT00316225 on ClinicalTrials.gov Archive Site |
- Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: cycle 1, cycle 2 ] [ Designated as safety issue: Yes ]
- Pemetrexed dosing recommendations [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
|
| This study will identify increases in the toxicity of pemetrexed, assess the clinical relevance of any alterations in pemetrexed pharmacokinetics and provide pemetrexed dosing recommendations, in patients with third-space fluid. |
| |
| Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen |
| A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid |
This study will test the effects of pemetrexed on mesothelioma and lung cancer patients with fluid around their lungs or abdomen. |
| |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
- Non-Small Cell Lung Cancer
- Mesothelioma
- Lung Neoplasms
|
| Drug: pemetrexed |
| |
| |
| |
| Completed |
| 31 |
| March 2009 |
| March 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer or mesothelioma
- Presence of third-space fluid (fluid around the lungs or abdomen).
- Measurable lesions are not required for enrollment in this study.
- Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the sharp toxic effects the anticancer treatment.
- Estimated life expectancy of at least 8 weeks.
Exclusion Criteria:
- Have received treatment within the last 30 days with a drug that was not a marketed product
- Active infection that, in the opinion of the investigator, would not allow the patient to tolerate therapy.
- Pregnancy.
- Breast-feeding.
- Significant weight loss (that is, greater than or equal to 10% of body weight) over the 6 weeks before study entry.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Denmark, Germany, Spain |
| |
| NCT00316225 |
| Chief Medical Officer, Eli Lilly |
| 10426, H3E-MC-JMHX |
| Eli Lilly and Company |
|
| Study Director: |
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) |
Eli Lilly and Company |
|
|
| Eli Lilly and Company |
| March 2009 |