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New 3 drug trial

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  • New 3 drug trial

    I just though this might be of interest to someone since there are a few people going through high dose chemotherapy. They are using 3 drugs with little cross resistance to BEP / VIP which is a true step forward in the treatment of refractory germ ecll tumors. I know of one study out of Greece with a similar approach wich yeilded some good results concidering the patient group. This even offers hope for long term cure in those who have failed HD chemo with BMT.


    This is a study for patients with advanced testicular cancer. This research study involves treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational chemotherapy combination. This study is for patients who have not responded to standard cisplatin-containing chemotherapy or the cancer has returned after such treatment.

    This research is being done to assess the effectiveness of the proposed combination of medications for this type of cancer.

    Condition Intervention Phase
    Extra Gonadal Germ Cell Neoplasm
    Drug: Gemcitabine, oxaliplatin, paclitaxel
    Phase II

    MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Endocrine Diseases; Testicular Disorders
    Genetics Home Reference related topics: Cancer; Endocrine Diseases

    Study Type: Interventional
    Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

    Official Title: A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma

    Further study details as provided by Norris Comprehensive Cancer Center:
    Study start: November 2004


    Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Male
    Inclusion Criteria:

    Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure
    Must have refractory germ cell neoplasm defined as one or more of the following: [a] patients who progress during or within 4 wks of cisplatin-containing tx, OR [b] patients who have failed initial salvage chemotx regimens, including: high-dose tx (chemotx with stem cell support), POMB-ACE tx, VeIP, or VIP.
    Must have one or more of the following (check all that apply): [a] Unidimensionally measurable dz assessed within 14 days prior to registration, OR [b] Elevated β-HCG >20 mIU assessed within 24-48 hrs prior to registration, OR [c] AFP >2 x uln assessed within 5-7 days prior to registration.
    Note: Soft tissue dz, which has been radiated in the 2 mos prior to registration, is not assessable as measurable dz.

    X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration
    May have received prior surgery or RT. At least 3 wks must have elapsed since completion of previous tx and must have recovered from any adverse effects.
    Zubrod PS less than or equal to 2
    greater than of equal to 16 yrs of age
    AGC greater than or equal to 1.5; platelets greater than or equal to 100,000
    Total bilirubin <2.5 x uln; SGOT and alk phos <5 x uln (obtained within 14 days prior to registration)
    LDH (obtained within 7 days prior to registration)
    Creatinine <2.5 x uln or calc or meas CrCl greater than or equal to 40 ml/min (obtained within 14 days prior to registration; patient must not be on renal dialysis)
    Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration)
    Men of reproductive potential must agree to use effective contraceptive method
    Signed informed consent (including HIPAA authorization)
    Exclusion Criteria:

    Prior tx with cytotoxic or experimental agents within 14 days prior to registration
    Evidence of concurrent infection (T>96.8F but <101.5F; WBC <11.0 unless these values can be ascribed to another tumor-related phenomena)
    Other prior malignancy, except adequately treated basal cell or squamous cell skin ca, adequately treated stage I or II ca from which patient is currently in CR, or any other ca from which patient has been disease-free for 5 yrs
    Location and Contact Information

    Please refer to this study by identifier NCT00183820

    Omid Hamid, MD 323/865-0813 [email protected]

    Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States; Recruiting
    Omid Hamid, MD 323-865-0813 [email protected]

    Study chairs or principal investigators

    David Quinn, MD, Principal Investigator, Norris Comprehensive Cancer Center

  • #2
    Looks like an interesting study with gemzar/taxal combo being used with oxaliplatnin.

    Thanks for finding this. I'm gonna keep my eye on this one.
    Wife of Kevin Murphy
    Diagnosed 7/16/04 100% Choriocarcinoma
    Oriechtomy 7/20/04
    4xBEP 8/04-11/04 BHCG:1200 (lung only)
    Rediagnosed 12/27/04 BHCG: 50
    1xVIP 1/05 (lung)
    HDC/Stem cell Indiana 2/05-4/05 BHCG: 51-4.5 (lung)
    HDC failure 5/05
    3xGemzar/Taxol 6/05-9/05 (lung only)
    VP-16 w/Avastin 9/05-1/06 (lung only)
    Cyberknife 5" lung tumor 2/06
    cyberknife 6 brain tumors 3/06
    1xOxaliplatnin 3/06 (liver, lungs, kidneys, left hip)
    Passed away 4/13/2006