A Phase 1 Study in Patients With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: LY573636; Pemetrexed
Intervention description: Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).
Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Patients are pretreated with folic acid [350 micrograms (µg) to 1000 µg orally, daily], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone [4 milligrams (mg) orally, twice daily or equivalent].; 375 to 500 milligrams per square meter (mg/m^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).
Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Intervention MeSH terms: Pemetrexed
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid tumors

Summary:

      The primary objective of this study is to determine the maximum tolerated dose (MTD) regimen
      for the combination therapy of LY573636 and pemetrexed that may be safely administered to
      patients with a solid tumor that is not amenable to curative therapy.
    

Eligibility criteria:

        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

        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