Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Lycopene
Intervention description: Given IV; Given PO
Intervention MeSH terms: Lycopene; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 21 Years
Healthy volunteers: No
Keywords: docetaxel; lycopene; prostate cancer

Summary:

      This phase II trial evaluated the impact of giving docetaxel together with lycopene
      supplements in treating patients with hormone-resistant prostate cancer not previously
      treated with chemotherapy. Drugs used in chemotherapy, such as docetaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Chemoprevention is the use of certain drugs, such as lycopene, to keep cancer from
      forming. Giving docetaxel together with lycopene may be an effective treatment for prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have a histological diagnosis of adenocarcinoma of the prostate and 2
             rising pre-study PSA values >= 1 ng/ml at least 1 week apart within 28 days prior to
             enrollment

          -  Patients must be unresponsive to androgen-deprivation therapy (ADT), as indicated by a
             rising PSA level above the ADT nadir

          -  Patient must not have received chemotherapy, biologic therapy, or any other
             investigational drug for any reason within 28 days prior to start of therapy, and must
             have recovered from toxicities of prior therapy to grade 1 or less

          -  Patients must have been surgically or medically castrated; if the patient is being
             treated with medical castration, he must be willing to continue this treatment for the
             duration of the study; ADT should not be initiated, terminated, or dose-adjusted
             during the study

          -  Prior external beam radiation therapy (to less than 30% of the bone marrow only) is
             allowed; at least 28 days must have elapsed since the completion of radiation therapy
             and the patient must have recovered from side effects; prior treatment with
             samarium-153 or strontium-86 is allowed if at least eight weeks have elapsed since
             dosing, and all toxicities have resolved to grade 1; soft tissue disease which has
             been radiated in the prior 2 months is not assessable as measurable disease

          -  Patients may have received prior surgery; however, at least 21 days must have elapsed
             since completion of surgery and the patient must have recovered from all side effects

          -  Normal serum bilirubin and serum glutamic oxaloacetic transaminase (SGOT) or serum
             glutamic pyruvate transaminase (SGPT) =< 1.5 x the institutional upper limit of normal
             obtained within 14 days prior to start of therapy; liver function tests should be
             evaluated prior to each treatment

          -  Serum creatinine =< 1.5 x the institutional upper limit of normal obtained within 14
             days prior to start of therapy

          -  Men of child bearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months thereafter

          -  Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count >= 1,500/microliter (mcL)

          -  Hemoglobin of >= 8.0gm/dL

          -  White blood cell count > 2,500/mcL

          -  Platelets >= 100,000/mcL

          -  Patients with lower values may participate if, in the opinion of the investigator, the
             cytopenias are the result of bone marrow involvement with active prostate cancer

          -  Patients must be able to take oral medications

          -  All patients must be informed and must sign and give written informed consent in
             accordance with institutional and federal guidelines; patients who are unable to
             comply with study and/or follow-up procedures are ineligible

        Exclusion Criteria:

          -  Uncontrolled brain or spinal cord metastases

          -  History of congestive heart failure or myocardial infarction within the previous six
             months

          -  History of allergy or hypersensitivity to any component of the study drugs

          -  Evidence or history of a bleeding diathesis or coagulopathy, including therapy-induced
             coagulopathy

          -  Presence of chronic diarrhea (> grade 1 by Common Toxicity Criteria (CTC)), short
             bowel syndrome, pancreatic insufficiency, or malabsorption

          -  Presence of any severe or uncontrolled concurrent medical condition which, in the
             opinion of the investigator, would increase the risk of serious toxicity from the
             study drugs

          -  Concurrent use of any vitamin, herb, or mineral supplements for at least 14 days prior
             to start of therapy