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Vaginal dryness is a common problem for which effective and safe nonestrogenic treatments are needed. Based on preliminary promising data that pilocarpine attenuated vaginal dryness, the current trial was conducted. A double-blind, placebo-controlled, randomized trial design was used to compare pilocarpine, at target doses of 5 mg twice daily and 5 mg four times daily, with a placebo. Vaginal dryness was recorded by patient-completed questionnaires at baseline and weekly for 6 weeks after study initiation. The primary endpoint for this study was the area under the curve summary statistic composed of the longitudinal responses obtained at baseline and through the 6 weeks of treatment to a numerical analogue scale asking patients to rate their perceived amount of vaginal dryness. The primary analysis was carried out by a single t test using a two-side alternative to compare the collective pilocarpine treatment arms with the collective placebo arms. A total of 201 patients enrolled in this trial. The primary analysis, comparing vaginal dryness symptoms in the collective pilocarpine arms against the placebo arm, did not reveal any benefit for the pilocarpine treatment. This finding was confirmed by other secondary analyses. Toxicity evaluation revealed more nausea, sweating, rigors, and urinary frequency with the pilocarpine arms compared with the placebo arm.

OBJECTIVE To prospectively assess whether low-molecular-weight heparin (LMWH) provides a survival benefit in patients with advanced cancer. PATIENTS AND METHODS Between December 1998 and June 2001, we performed a randomized controlled study of patients with advanced cancer. Initially, the study was double blinded and placebo controlled, with the patients receiving daily injections of 5000 U of LMWH or saline. However, because of low accrual midway through the study, the placebo injection arm was eliminated, and the study became open labeled, with patients receiving either LMWH injections plus standard clinical care or standard clinical care alone. The primary study end point was overall survival. RESULTS Of 141 patients randomized to this clinical trial, 3 dropped out, leaving 138 patients. The median survival time was 10.5 months (95% confidence interval, 7.6-12.2 months) for the combined standard care and placebo groups. The median survival time for the combined LMWH arms was 7.3 months (95% confidence interval, 4.8-12.2 months). These median survival times were not significantly different (log-rank P =.46). The median survival times for the blinded and unblinded LMWH groups were 6.2 months and 9.0 months, respectively. The median survival times were 10.3 months for the blinded placebo arm and 10.5 months for the standard care arm. The rate of severe or life-threatening venous thromboembolism was 6% in the LMWH arms and 7% in the control arms. The rate of severe or life-threatening bleeding was 3% in the LMWH arms and 7% in the control arms. CONCLUSION This trial was unable to demonstrate any survival benefit for LMWH in patients with advanced cancer.

Intramedullary spinal cord metastasis (ISCM) is an unusual occurrence in systemic cancer, occurring in as few as 2% of autopsy cases and also represents 8.5% of all cases of central nervous system metastases. Although ISCM from small cell lung carcinoma is well documented, ISCM from non-small cell lung carcinoma of the lung is rarely diagnosed prior to the patients' demise and very little data regarding outcomes exists in such patients. We present the results of our observational case series to better delineate the presentation and clinical course of this uncommon entity which shows that ISCM may present atypically and should be considered in any patient with a previous history of bronchogenic carcinoma and neurologic symptoms.

A phase II study of cyclophosphamide, cisplatin, and leuprolide acetate after debulking of stage III or IV ovarian carcinoma was conducted in 33 patients through a cooperative group study involving 11 institutions. The intent was to determine whether the addition of a gonadotropin-releasing hormone analogue would alter the response rates and toxicity profile of cyclophosphamide and cisplatin in patients with advanced ovarian cancer. Twenty-nine patients completed all 6 planned cycles. Of the 19 patients who had second-look laparotomy, 12 had persistent disease and 7 were negative for disease. The use of a gonadotropin-releasing hormone with combined chemotherapy did not alter the toxicity profile or the effectiveness of chemotherapy when comparisons were made with historical controls.