Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

NCT ID: NCT00475657

Last Updated: 2009-05-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-04-30

Brief 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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

pemetrexed

Intervention Type: DRUG

500 mg/m2, intravenous (IV), every 21 days x 6 cycles

cisplatin

Intervention Type: DRUG

75 mg/m2, intravenous (IV), every 21 days x 6 cycles

Interventions

pemetrexed

500 mg/m2, intravenous (IV), every 21 days x 6 cycles

Intervention Type: DRUG

cisplatin

75 mg/m2, intravenous (IV), every 21 days x 6 cycles

Intervention Type: DRUG

Other Intervention Names

LY231514; Alimta

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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.

A 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.

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.

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, , Spain

Countries

Spain

Other Identifiers

H3E-XM-S113

Identifier Type: -

Identifier Source: secondary_id

11473

Identifier Type: -

Identifier Source: org_study_id