Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

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

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.

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.