Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen

NCT00316225 | Completed Phase 2 Results

• 2 other identifiers: 10426H3E-MC-JMHX
• Study Type: interventional
• Target: 31
• Locations: 3 countries
• Sites: 3

Brief Summary

This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen.

Conditions

Non-small Cell Lung Cancer; Mesothelioma; Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overview of Adverse Events

  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.

  baseline, up to 18 weeks

Secondary Outcomes (4)

• Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities

  baseline, up to 18 weeks

• Pemetrexed Population Pharmacokinetics (PK): Clearance

  Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion

• Pemetrexed Population Pharmacokinetics: Volume of Distribution

  Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion

• Discontinuations Due to Adverse Events

  baseline, up to 18 weeks

Other Outcomes (1)

• Overall Tumor Response

  baseline, up to 18 weeks

Study Arms (1)

Pemetrexed

EXPERIMENTAL

Pemetrexed 500 mg/m\^2 intravenous (IV) every 21 days for 6 cycles

Drug: pemetrexed

Interventions

pemetrexed DRUG

500 milligrams per meter squared (mg/m\^2) IV every 21 days for 6 cycles

Also known as: LY231514, Alimta

Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Brain metastases.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Copenhagen, 2100, Denmark

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hanover, 30625, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madrid, 28041, Spain

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Mesothelioma; Lung Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 18, 2006
• First Posted: April 20, 2006
• Study Start: December 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 9, 2010
• Results First Posted: July 9, 2010

Record last verified: 2010-06

Locations

DE (1); DK (1); ES (1)