Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Pemetrexed

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.