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Objectives. A previously reported phase 2 trial suggested substantial clinical activity associated with the combination of a platinum agent and tamoxifen in t he treatment of platinumresistant ovarian cancer. We wished to confirm or refute this observation in a patient population with well-characterized platinum-res istant disease. Methods. Patients with ovarian or fallopian tube cancers or prim ary carcinoma of the peritoneum whose disease had either failed to respond to a platinum-based regimen or had responded but experienced a “treatment-free int erval (TFI)”of ≤3 months, or if the TFI was >3 months they had been retreated and failed a platinum-based program, were eligible for entry into this phase 2 single institution protocol. Carboplatin (AUC5)was delivered on a q-21 day cycl e. Tamoxifen was administered at a dose of 80 mg/day for the first cycle, and th en reduced to 40 mg/day. Treatment was to be continued until evidence of disease progression or unacceptable toxicity. Results. Fourteen patients were treated o n this phase 2 trial. In addition to being platinum-resistant, 10 patients had cancers that were also documented to be taxane-resistant (similar criteria to t hat defined above for platinum). While treatment was generally well tolerated, t here were no objective (measurable disease or CA-125 response criteria) or subj ective responses to this treatment program. Conclusion. In this phase 2 trial, w e have been unable to confirm a meaningful level of clinical activity for the co mbination of carboplatin plus tamoxifen in a patient population with well-characterized platinum-resistant ovarian cancer.
Objectives. A previously reported phase 2 trial suggested substantial clinical activity associated with the combination of a platinum agent and tamoxifen in t he treatment of platinum-resistant ovarian cancer. We wished to confirm or refute this observation in a patient population with well-characterized platinum-res Patients with ovarian or fallopian tube cancers or prim ary carcinoma of the peritoneum whose disease had either failed or who responded to a platinum-based regimen or had responded but experienced a “treatment-free int erval (TFI)” of ≤ 3 months, or if the TFI was> 3 months they had been retreated and failed a platinum-based program, were eligible for entry into this phase 2 single institution protocol. Carboplatin (AUC5) was delivered on a q-21 day cycl e. Tamoxifen was administered at a dose of 80 mg / day for the first cycle, and reduced to 40 mg / day. Treatment was to be continued until evidence of disease progression or unacceptable toxicity. Results. Fourteen patients were treated on this phase 2 trial. In addition to being platinum-resistant, 10 patients had cancers that were also documented to be taxane-resistant (similar criteria to t hat defined above for platinum). tolerated, t here were no objective (measurable disease or CA-125 response criteria) or subj ective responses to this treatment program. Conclusion. In this phase 2 trial, we have been unable to confirm a meaningful level of clinical activity for the co mbination of carboplatin plus tamoxifen in a patient population with well-characterized platinum-resistant ovarian cancer.