Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer
- 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
- The patient or his/her legal representative must sign an informed consent document.
- Patients must be at least 18 years of age.
- Having received treatment for the last 30 days with a drug that has not obtained
- 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
- Concurrent administration of any other anti-tumor treatment.
- Severe renal failure.
- Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS)
- Inability or unwillingness to take folic acid and vitamin B12 supplements.
- Inability to take corticoids.