Chemotherapy for Patients With Non-Small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT00380718
• Recruitment Status: Completed
• First Posted: September 26, 2006
• Results First Posted: October 6, 2009
• Last Update Posted: November 16, 2010
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Study Description

Brief Summary:

The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC).

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer	Drug: pemetrexed	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label Single-Arm Phase IV Study of Pemetrexed in Taiwanese Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
• Study Start Date: November 2006
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: November 2009

Arms and Interventions

Arm

Intervention/treatment

Experimental: Pemetrexed

Drug: pemetrexed; 500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease. *Toxicity acceptable if none of the following toxicities recorded at any time during Cycle 1: Platelets <50 x 10^9/L; absolute neutrophil count <1.0 x 10^9/L; Stomatitis/pharyngitis/esophagitis/diarrhea Grade >2; Skin Grade >2; Serum bilirubin >3.0 x upper limit of normal (ULN); alanine aminotransferase/aspartate aminotransferase >10 x ULN; Other non-hematologic toxicities Grade >2 (except nausea, vomiting).; Other Names: LY231514; Alimta

Outcome Measures

Primary Outcome Measures :

1. Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]) [ Time Frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]
   The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.

Secondary Outcome Measures :

1. Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR]) [ Time Frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]
   DCR was defined as the proportion of best overall response of CR, PR, and SD. DCR=(CR+PR+SD)/Number of participants. Response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
2. Overall Survival [ Time Frame: baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment) ]
   Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last follow-up visit.
3. Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]
   Time to PFS was defined as the time from the date of enrollment to the date of the first of the following events: objective disease progression or death due to any cause. Survival time frame includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment. Patients were censored if their disease had not progressed, treatment was discontinued due to an undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.
4. Duration of Response [ Time Frame: time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]
   Duration of overall tumor response was measured from the time of first documentation of complete response or partial response (whichever status was first recorded) until the date of progression-free survival, with censoring defined as: disease had not progressed, treatment was discontinued due to undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.
5. Time to Treatment Failure [ Time Frame: baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]
   Time to treatment failure was define as the time from the date of enrollment to the date of the first of the following events: objective disease progression, death due to any cause, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. Time to treatment failure for participants who were still participating in the study without treatment failure at the time of analysis were treated as censored at the date of the last tumor assessment.
6. Time to Tumor Progression [ Time Frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]
   Time to documented tumor progression was defined as the time from the date of enrollment to the first date of documented disease progression. Time to documented disease progression was censored at the date of death for participants who had not had documented disease progression. Otherwise, the censoring rules were the same as for Progression-Free Survival.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
• Patients' NSCLC must have progressed following one chemotherapy regimen for palliative therapy with or without subsequent targeted biological therapy
• Disease status must be that of measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria:

• Concurrent administration of any other tumor therapy
• Pregnancy or breast feeding
• Serious concomitant disorders
• Inability or unwillingness to take folic acid or vitamin B12 supplementation

Contacts and Locations

Locations

Taiwan

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.

Taichung, Taiwan, 407

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.

Taipei, Taiwan, 112

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• 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

More Information

• Responsible Party: Chief Medical Officer, Eli Lilly
• ClinicalTrials.gov Identifier: NCT00380718
• Other Study ID Numbers: 10720; H3E-MC-JMIC ( Other Identifier: Eli Lilly and Company )
• First Posted: September 26, 2006
• Results First Posted: October 6, 2009
• Last Update Posted: November 16, 2010
• Last Verified: November 2010

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors