Goserelin, clinical studies

Phase I and Phase II clinical studies with goserelin 308... 

PHASE 1 AND PHASE II CLINICAL STUDIES WITH GOSERELIN... 

Early clinical studies established between the Institute and the Yorkshire Prostatic Cancer Group [80] showed that daily subcutaneous administration of goserelin (Zoladex) to patients with histologically proven carcinoma of the prostate, with or without metastatic disease, resulted in a decrease in the concentration of testosterone in serum to castrate levels. Four patients received 250/ig/day for periods up to 3 months and four received 100 /ig daily. In the four patients on the higher dose, the plasma testosterone concentration reached this level by day 14, whereas on the daily 100 fig dose, castrate levels were achieved after 5-6 weeks (Figure 3.5). Comparable changes were observed in the serum levels of FSH and LH, and were associated with a... 

Taylor CW, Green S, Dalton WS, Martino S, Rector D, Ingle JN, Robert NJ, Budd GT, Paradelo JC, Natale RB, Bearden JD, Mailliard JA, Osborne CK. Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer an intergroup study. J Clin Oncol 1998 16(3) 994-9. 

Zoledronic acid has also been investigated in the prevention of cancer treatment-induced bone loss in 401 premenopausal women receiving adjuvant endocrine therapy for hormone-responsive breast cancer in a randomised, open-label. Phase 111 clinical trial [76]. In this study, patients received tamoxifen and goserelin with or without zoledronic acid (4 mg i.v. every 6 months) versus anastrozole and goserelin with or without zoledronic acid (4 mg i.v. every 6 months) for 3 years. The combination of zoledronic acid with endocrine therapy was well tolerated and was not associated with changes in renal function in this patient population. Over 3 years, 2, 904 serum creatinine measurements were taken, the mean serum creatinine level was 0.78 + 0.17 mg/ dl, and no patient had serum creahnine levels that exceeded 1.5 times the upper limit of normal [76]. 

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