A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned
Phase 2
Completed
- Conditions
- Carcinoma, Small Cell
- Registration Number
- NCT00191750
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To better understand any side effects of pemetrexed
Trial Locations
- Locations (1)
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
🇺🇸Dallas, Texas, United States