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

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

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Key information

Conditions

Carcinoma, Small Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase II Trial of ALIMTA in Relapsed Small Cell Lung Cancer

Important dates

Study start: 2004
Study completion: 2006
First posted: Sep 19, 2005
Registry last updated: Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed