Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with relapsed or chemotherapy-refractory SCLC have a dismal prognosis. Unfortunately, available treatments result in few durable responses. Pemetrexed is a well-tolerated agent, which is active in NSCLC. Since chemotherapy agents, which are active in NSCLC, are usually also active in SCLC, this trial will examine the efficacy and activity of pemetrexed in this palliative setting

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoosier Cancer Research Network
• Collaborators: Eli Lilly and Company; Walther Cancer Institute
• Treatments: Pemetrexed

Criteria

Inclusion Criteria:

• Histological or cytological proof of neuroendocrine cancers (including small cell cancers of any site [including lung] or poorly differentiated neuroendocrine cancers of the lung with (unidimensionally) measurable disease as per the RECIST criteria

• Chemoresistant or chemosensitive disease

• Patients must have received treatment with at least one but not more than 2 prior chemotherapy regimens, including one regimen containing a platinum agent

• Radiation therapy must have completed their radiation at least 14 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to < grade 1 or baseline prior to registration

• Negative pregnancy test

Exclusion Criteria:

• No clinically significant infections as judged by the treating investigator

• No symptomatic CNS metastasis

• No radiation to > 25% of the marrow containing spaces

• No previous treatment with pemetrexed

• No uncontrolled pleural effusions

• No current breastfeeding