FINAL Clinical Trials
To inquire about current clinical trials, please call 1-800-59-NORRIS (1-800-596-6774) and refer to the study code and physician.
BREAST
A new oral drug for advanced breast cancer, Targretin, will be given to patients daily in a randomized trial to test various dosage levels. To be eligible, patients must have previously been given tamoxifen adjuvant therapy with or without chemotherapy. There must also be a measurable tumor present so that response to the treatment can be assessed. Patients with visceral disease will be excluded if they are thought to be rapidly progressing. Study 1B-98-7, Christy Russell, M.D.
Women with metastatic breast cancer may be eligible for a non-blinded, randomized, multicenter study comparing the chemotherapeutic agent docetaxel in combination with doxorubicin and cytoxan versus 5FU in combination with doxorubicin and cytoxan as first-line therapy. Patients may have undergone prior hormonal and radiation therapy if their disease has since progressed; however, only prior adjuvant or neoadjuvant chemotherapy is permitted. Patients who have previously been given taxoids and patients with brain involvement or other serious illness will not be eligible. Study 1B-98-6, Christy Russell, M.D.
Research suggests that five years of tamoxifen therapy is ideal, but no one knows what treatment, if any, is best to use after tamoxifen is stopped. In this study, breast cancer patients who have been taking tamoxifen for at least five years will be randomized to either receive a new drug, letrozol, or a placebo. (Letrozol is an enzyme inhibitor that lowers estrogen levels.) Treatment will be given daily for five years. Eligible patients must be postmenopausal. Study SWOG-JMA17, Christy Russell, M.D., and Darcy Spicer, M.D.
OVARY
Patients with ovarian cancer who have failed or relapsed after a platinum-based chemotherapy regimen may be eligible to test the anti-angiogenic agent IM862, which will be given intranasally either daily or every other day. Study 5O-98-4, Agustin Garcia, M.D.
MELANOMA
A new drug that inhibits angiogenesis, IM862, will be offered to patients with stage III or IV metastatic melanoma that is surgically incurable after attempted curative therapy. IM862 will be given intranasally twice a day. Candidates for this trial must have received no other therapy within the past month to be eligible. Study 10M-98-3, Jeffrey Weber, M.D., Ph.D.
PANCREAS
Patients with locally advanced or metastatic pancreatic cancer that cannot be surgically removed may be eligible for a study comparing the anti-angiogenesis agent BAY12-9566 with the chemotherapy drug gemcitabine. BAY12-9566 will be given orally twice a day; gemcitabine will be infused weekly. Both treatments will be followed by one week's rest every eight weeks. Patients who have had prior chemotherapy other than 5FU given concurrently with radiation therapy for management of local disease will be excluded. Study 3P-98-1, Heinz-Josef Lenz, M.D.
BLADDER
Patients with locally advanced or metastatic transitional cell cancer of the urothelium that does not respond to surgery or radiotherapy may be eligible for a study of gemcitabine and paclitaxel. The intravenous regimen will be given every two weeks to those patients who have measurable disease by which to follow tumor response. No more than two prior chemotherapy regimens for recurrent or metastatic disease will be allowed. Study 4B-98-2, Derek Raghavan, M.D., Ph.D.
PROSTATE
A new platinum analog, JM-216, will be investigated in a randomized trial for patients with adenocarcinoma of the prostate who have painful metastatic disease despite hormone therapy. Patients will receive oral doses of either JM-216 plus prednisone or placebo plus prednisone. Patients who have had prior therapy with a platinum compound or more than one prior cytotoxic chemotherapy regimen will be excluded. Some prior radiotherapy may be allowed, but no previous strontium will be permitted. Study 4P-98-6, Derek Raghavan, M.D., Ph.D.
Patients with androgen-independent prostate cancer who have rising PSA levels and have failed conventional anti-androgen therapy may be eligible for a trial of a new anti-cancer agent. SAM486 will be given intravenously. Eligible patients will have had only one prior chemotherapy regimen, and that therapy must have been given before the anti-androgen therapy. Additionally, patients must currently be receiving endocrine therapy or be surgically castrated. Study 4P-98-7, Derek Raghavan, M.D., Ph.D.
BRAIN
A new antitumor agent, Temodal (temozolomide), will be offered to patients with malignant glioma whose tumor has failed to respond to radiation therapy. The drug will be given orally once a day for five days. Patients who have previously been given decarbazine will not be permitted in the study. In addition, patients must have recovered from any side effects from previous treatments in order to be admitted to the study. Study 6B-98-2, Thomas Chen, M.D., Ph.D.
