Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00475657
• Other study ID #: 11473
• Secondary ID: H3E-XM-S113
• Status: Terminated
• Phase: Phase 2
• First received: May 16, 2007
• Last updated: May 22, 2009
• Start date: October 2007
• Est. completion date: April 2008

Study information

• Verified date: May 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).

• Functional stage from 0 to 2 of the ECOG functional scale

• No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.

• Previous bone marrow radiotherapy less than 25% is allowed.

• There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.

• Appropriate organic function.

• Life expectancy estimated at 12 weeks minimum.

• Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.

• The patient must be compliant and located close to the trial area for appropriate follow-up.

• The patient or his/her legal representative must sign an informed consent document.

• Patients must be at least 18 years of age.

Exclusion Criteria:

• Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.

• Having participated in a previous pemetrexed trial.

• Mixed histologic diagnosis of SCLC and NSCLC.

• Concurrent illness.

• Having an active infection.

• Severe cardiac disease.

• Having received recently or concurrently a vaccine against yellow fever.

• Having suffered a previous malignant process other than SCLC.

• Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.

• Clinically relevant fluid accumulation in the third space.

• Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.

• Concurrent administration of any other anti-tumor treatment.

• Severe renal failure.

• Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.

• Inability or unwillingness to take folic acid and vitamin B12 supplements.

• Inability to take corticoids.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
• cisplatin
75 mg/m2, intravenous (IV), every 21 days x 6 cycles

Locations

Country	Name	City	State
Spain	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ferrol
Spain	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	La Coruña
Spain	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lugo
Spain	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ourense
Spain	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Santiago de Compostela
Spain	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate		baseline to measured progressive disease	No
Secondary	Overall Survival		baseline to date of death from any cause	Yes
Secondary	Progression Free Survival		baseline to measured progressive disease	No
Secondary	Duration of Response		time of response to progressive disease	No
Secondary	Stable Disease Rate		baseline to measured progressive disease	No

External Links

•   Lilly Clinical Trial Registry