CLINICAL TRIALS

All Sites

Taxol" and Doxil" will be combined in study 0C-95-2 for patients with advanced malignancies. Both drugs have been tested in a wide variety of clinical settings. Doxil (liposomal anthracycline) is an investigational product that is enclosed in fat droplets which circulate in the bloodstream for days after administration. Treatment will be administered every three weeks in an outpatient setting. Prior therapy with doxorubicin is not permitted. No more than two prior systemic chemotherapy regimens given within the past 30 days are allowed. The prinicpal investigator is Franco Muggia, M.D. For more information contact the nurse coordinator, Susan Jeffers, R.N., at (213) 764-0455.

Breast

Franco Muggia, M.D., is the principal investigator for the following two breast studies. For details contact nurse coordinator Susan Jeffers, R.N., at (213) 764-0455.

1B-95-4 is a randomized two-section study for patients with breast cancer. In section I of the study, paclitaxel will be given alone as a three-hour infusion. In section II, the drug PSC 833 will be given with paclitaxel to see if PSC 833 will improve or lengthen tumor response. PSC 833 is an oral experimental drug that is thought to interfere with P-glyco-protein, a tumor cell membrane component that may be responsible for resistance to paclitaxel. The study requires that a lesion be readily accessible for biopsy. Prior treatment with Taxol is not allowed. Eligible patients must have failed an adjuvant anthracycline-based chemotherapy within six months and had no chemotherapy for advanced disease or must have received only one prior anthracycline-based chemotherapy for advanced disease. If hormonal therapy was given, at least two weeks must have passed since the last dose.

A second breast trial, 1B-96-2, is for patients who have failed previous treatment with paclitaxel. This study will be using Capecitabine, an oral drug chemically related to 5-fluorouracil. Eligible patients must have been treated with at least two, but not more than three, other chemotherapeutic regimens (including paclitaxel). Prior severe reactions to 5-fluorouracil and participation in any investigational drug study within four weeks preceding treatment start would preclude patient entry into this trial. Capecitabine will be given orally two times daily for two weeks followed by one week rest period.

Prostate

Ronald Natale, M.D., is the principal investigator for the following two prostate studies. For further information contact Sue Zaretsky, R.N., the nurse coordinator at (213) 764-0459.

Doxil will be used in the treatment of prostate cancer (4P-95-2). This drug is described in the section "All Sites." In this study, Doxil will be given alone every 28 days. To be eligible, patients must have failed hormonal therapy. Additionally, hormones must be discontinued 30 days prior to entry into the study and progression documented again after withdrawl of anti-androgen therapy. Cardiac function will be evaluated by MUGA scan to determine eligibility.

The second prostate trial, SWOG-9407 is open for patients with metastatic adenocarcinoma of the prostate who have received hormonal therapy and are no longer responding to this treatment as demonstrated by a rising PSA. Eligibility criteria permits prior administration of chemotherapy and radiation therapy (to less than 25 percent of the bone marrow), however, previous strontium therapy is not allowed. Patients may have had an orchiectomy in the past. Two oral agents, estramustine and etoposide, will be given daily over a three-week period every month.

Gastric

A new investigational drug, Tomudex, is being used in protocol 3S-95-1, a study for patients with previously untreated, metastatic stomach cancer. Tomudex acts as a thymidylate synthase (TS) inhibitor. Drugs which prevent the expression of the enzyme TS may produce better tumor response. This multi-institutional trial requires that eligible patients be of good performance status and are fully recovered from any prior surgery. Patients who have gastric cancer thought to be resectable are not candidates for this trial. Treatment will consist of Tomudex every three weeks. The principal investigator is Gail Leichman, M.D. For further information, contact her at (213) 764-3907.

Head and Neck

RTOG-9501 is a randomized trial of radiation therapy versus radiation therapy plus chemotherapy. It is available for patients who have had surgery for their head and neck tumor, although primary sites of the lip, nasopharynx, and sinuses are excluded. All visible evidence of tumor needs to have been removed at surgery, but because of the number of nodes removed, it may be possible that microscopic tumor is still present. Randomization and entry into this study must be completed within 56 days of that survey. Metastatic disease and prior administration of chemotherapy or radiation therapy would preclude participation in this study. The principal investigator is Oscar Streeter, M.D. For complete information about study entry, contact data manager Shaun Mason at (213) 764-3056.

Kaposi's Sarcoma

A randomized study comparing an investigational drug, ALRT1057 (9-cis retinoic acid) topical gel, to a gel containing no drug, is open. Protocol 17K-96-2 is available to patients with a proven diagnosis of Kaposi's sarcoma and who are HIV positive. There must be at least six lesions to which the gel can be applied. These lesions cannot have been treated within the past 60 days with a prior topical or local therapy. At least 30 days should have lapsed since any systemic treatment was given, including large doses of vitamin A or other retinoid class drug. Gels will be applied three to four times per day for at least 12 weeks. The principal investigator is Parkash Gill, M.D. For further information, contact Bryon Espina at (213) 764-0371.


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