A Phase 1 Study in Patients With Solid Tumors

Inclusion Criteria

• •You must have a diagnosis of a solid tumor malignancy that is not amenable to curative therapy
• •You must have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) \[30 grams per liter (g/L)\]
• •You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• •You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures
• •Patients with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drugs
• •Your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory
• •You must be willing to take folic acid, Vitamin B12, or prophylactic steroids
• •You must able to interrupt the use of aspirin (other than an aspirin dose less than or equal to 1.3 grams per day) and/or other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents, such as piroxicam)
• •You must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, hormone therapy, or other investigational therapy for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia). Patients who have received whole-brain radiation must wait 90 days before starting study therapy.
• •You must sign an informed consent