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Phase II Trial of ALIMTA in Relapsed Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Small Cell

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Trial Information

Phase II Trial of ALIMTA in Relapsed Small Cell Lung Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

7209

NCT ID:

NCT00191750

Start Date:

July 2004

Completion Date:

September 2006

Related Keywords:

  • Carcinoma, Small Cell
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell

Name

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 physicianHouston, Texas  
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 physicianHickory, North Carolina  
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 physicianAurora, Colorado