A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned

Phase 2CompletedNCT00191750

Eli Lilly and Company80 enrolled

Overview

The purposes of this study are to determine 1) the safety of pemetrexed and any side effects that might be associated with it 2) whether pemetrexed can help patients with small cell lung cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how long and 4) to see if patients feel better while taking pemetrexed

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Small Cell

Interventions

PemetrexedDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of small cell lung cancer * One prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment * At least 18 years of age * Estimated life expectancy of at least 12 weeks * Ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours) Exclusion Criteria: * Have received treatment within the last 30 days with a drug that has not received FDA approval for any indication * Less than 2 weeks from radiation therapy * Other serious illness that would compromise the safety of the patient * Most second primary malignancies treated less than 5 years previously

Locations (3)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Aurora, Colorado, United States

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

To assess the antitumor activity for patients with both sensitive and refractory small cell lung cancer patients as measured by tumor response rate. To characterize the toxicities of pemetrexed in this patient population

Secondary Outcomes

To better understand any side effects of pemetrexed

Data from ClinicalTrials.gov

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