A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer

NCT ID: NCT00190840

Last Updated: 2007-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2005-10-31

Brief Summary

In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin. Since the introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety. Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with supplementation may increase pemetrexed's efficacy without unduly compromising safety. The present Phase 2 study will use pemetrexed dosing that is tailored to individual patient tolerance, and is an effort to determine the efficacy and safety of this approach in patients with advanced NSCLC who had prior chemotherapy.

Conditions

Carcinoma, Non-Small Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

pemetrexed

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• diagnosis of NSCLC
• Locally advanced or metastatic disease (Stage IIIB or IV).
• Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
• Disease status must be that of measurable disease as defined by RECIST criteria
• Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.

Exclusion Criteria

• Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
• Concurrent administration of any other tumor therapy.
• History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
• Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
• Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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.

Wollongong, New South Wales, Australia

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.

Chermside, Queensland, Australia

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Ashford, South Australia, Australia

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Fitzroy, Victoria, Australia

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Hong Kong, , China

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Alexandria, , Egypt

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Cairo, , Egypt

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Hyderabad, Andhra Pradesh, India

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Ludhiana, Punjab, India

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Chandigarh, , India

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Chennai, , India

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Delhi, , India

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Oradea, Bihor County, Romania

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Craiova, Dolj, Romania

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Bucharest, , Romania

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Iași, , Romania

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Goyang-si, Gyeonggi-do, South Korea

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.

Seoul, , South Korea

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

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.

Eskişehir, , Turkey (Türkiye)

Countries

Australia; China; Egypt; India; Romania; South Korea; Taiwan; Turkey (Türkiye)

Other Identifiers

H3E-AA-S037

Identifier Type: -

Identifier Source: secondary_id

6685

Identifier Type: -

Identifier Source: org_study_id