A Phase 1b Study of LY573636-sodium in Combination With Alimta (Pemetrexed) 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 g/dL (30 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
Exclusion Criteria:
- You cannot have received other investigational drugs within the last 30 days
- You cannot have other on-going serious illnesses including active bacterial, fugal,
or viral infections
- You cannot require regular, periodic paracentesis or thoracentesis
- You cannot have active brain metastasis
- You cannot currently be receiving warfarin (Coumadin®) therapy
- You cannot be pregnant or lactating
- You cannot have received prior Pemetrexed or LY573636
- You cannot have a second primary malignancy that could affect interpretation of the
study results