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A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer, Mesothelioma, Lung Neoplasms

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Trial Information

A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid

Inclusion Criteria:

- Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell
lung cancer (NSCLC) or mesothelioma

- Presence of third-space fluid (fluid around the lungs or abdomen).

- Eastern Cooperative Oncology Group Performance Status of 0 or 1.

- 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

- 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.

- Brain metastases.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overview of Adverse Events

Outcome Description:

Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome Time Frame:

baseline, up to 18 weeks

Safety Issue:


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


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

March 2009

Related Keywords:

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