Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: pemetrexed; cisplatin
Intervention description: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles; 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.