Oxaliplatin and Pemetrexed Disodium in Treating Patients With Refractory Hormone-Resistant Prostate Cancer
Condition: Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: oxaliplatin; pemetrexed disodium; questionnaire administration; laboratory biomarker analysis; reverse transcriptase-polymerase chain reaction; polymorphism analysis
Intervention description: Given IV; Given IV; Ancillary studies; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Oxaliplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well giving oxaliplatin and pemetrexed disodium together
      works in treating patients with refractory hormone-resistant prostate cancer. Drugs used in
      chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop
      the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
      oxaliplatin together with pemetrexed disodium may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed prostate cancer

          -  Measurable disease on computed tomography (CT) or evaluable disease on bone scan with
             an elevated PSA

          -  For patients who did not initially present with metastatic disease, definitive
             treatment with either radical prostatectomy or external beam radiation is permitted

          -  Documented progression on (a) two prior hormone treatments AND (b) one or two
             chemotherapy regimens

          -  Documented progression on two prior hormone therapies is defined as orchiectomy
             followed by anti-adrenal medication upon progression OR gonadotropin-releasing hormone
             (GnRH) analog +/- androgen receptor blocker with addition or subtraction upon
             progression; castrate level of testosterone must be documented at study entry

          -  Documented progression on taxane-based chemotherapy; in addition, patients may have
             failed a second prior chemotherapy regimen

          -  Palliative radiation therapy for metastatic disease is allowed only if less than 25%
             of total body bone marrow was irradiated; 28 days must have elapsed since completion
             of radiation therapy (RT) with bone marrow recovery; soft tissue disease irradiated in
             the prior 2 months may not be designated as measurable disease

          -  ECOG performance score of 0-2

          -  Absolute neutrophil count (ANC) >= 1500/uL

          -  Platelet count >= 100,000/uL

          -  Creatinine clearance >= 45 mL/min

          -  Serum total bilirubin =<1.5 mg/dL

          -  Alkaline phosphatase =< 3x the upper limit of normal (ULN) for the reference lab (=<
             5x the ULN for patients with known hepatic metastases) and no upper limit for patients
             with known bone metastases

          -  Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase
             (SGPT) =< 3x the ULN for the reference lab (=< 5x the ULN for patients with known
             hepatic metastases)

          -  Patients must be recovered from both acute and late effects of any prior surgery,
             radiotherapy or other antineoplastic therapy

          -  Patients or their legal representatives must be able to read, understand and provide
             informed consent to participate in the trial

          -  Men of childbearing potential must consent to use barrier contraception while on
             treatment and for 90 days thereafter

          -  Patients with pleural or peritoneal effusions are eligible

          -  Willingness and ability to take vitamin supplementation and steroid premedication as
             specified in protocol

          -  Patients with superficial bladder cancer or skin cancer who have second malignancy
             within 5 years which was removed with curative intent

        Exclusion Criteria:

          -  Active infection or with a fever >= 38.5 degrees Celsius (C) within 3 days of the
             first scheduled protocol treatment

          -  Patients with brain metastases

          -  Prior malignancy within the past 5 years, except for curatively treated basal cell or
             squamous cell carcinoma of the skin or superficial bladder cancer

          -  Known hypersensitivity to any of the components of oxaliplatin or pemetrexed

          -  Received radiotherapy to more than 25% of their bone marrow, or patients who received
             any radiotherapy within 4 weeks of entry

          -  Received treatment with strontium

          -  Receiving concurrent investigational therapy or who have received investigational
             therapy within 30 days of the first scheduled day of protocol treatment

          -  Life expectancy < 6 months

          -  Peripheral neuropathy >= Grade 2

          -  Any other medical condition, including mental illness or substance abuse

          -  History of allogeneic transplant

          -  Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously
             treated, or both)

          -  Inability to stop nonsteroidal anti-inflammatory drugs (NSAIDS) for a period of 2 days
             before, the day of, and 2 days following administration of Alimta; 5 days before, the
             day of, and 2 days following administration of Alimta for long-acting NSAIDS