George Wilding

Taxol in advanced, hormone‐refractory carcinoma of the prostate. A phase II trial of the eastern cooperative oncology group

Background. Recent clinical trials have documented activity for combinations of chemotherapeutic agents that target the microtubular apparatus in patients with hormone‐refractory prostate cancer. Taxol has a novel antimicrotubular mechanism, acting by stabilizing polymerized tubulin.

Phase III Trial of Methotrexate, Vinblastine, Doxorubicin, and Cisplatin versus Carboplatin and Paclitaxel in Patients with Advanced Carcinoma of the Urothelium: A Trial of the Eastern Cooperative Oncology Group

The regimens of carboplatin plus paclitaxel (CP) and methotrexate, vinblastine, doxorubicin, and cisplatin (M‐VAC) were compared in patients with advanced urothelial carcinoma.

Phase II Study of Paclitaxel plus Carboplatin in Patients with Advanced Carcinoma of the Urothelium and Renal Dysfunction (E2896) A Trial of the Eastern Cooperative Oncology Group

Chemotherapy options for the patients with advanced urothelial carcinoma and renal dysfunction are limited. The authors performed a Phase II trial of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction.

Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium: A trial of the Eastern Cooperative Oncology Group

Gemcitabine and docetaxel are active agents in advanced urothelial carcinoma. A Phase II trial of this combination was performed to determine the activity and toxicity of these agents in a multiinstitutional setting in patients previously treated with one prior chemotherapy regimen.

Results from a pilot Phase I trial of gefitinib combined with docetaxel and estramustine in patients with hormone‐refractory prostate cancer

Gefitinib, which is an orally active epidermal growth factor receptor tyrosine kinase inhibitor, has demonstrated activity against hormone‐refractory prostate cancer (HRPC) in preclinical studies. In this pilot Phase I trial, the authors evaluated the tolerability, efficacy, and pharmacokinetics of gefitinib combined with estramustine and docetaxel in patients with HRPC.

Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: Results of intergroup 0159/cancer and leukemia group B 9480

Research has suggested that men with hormone‐refractory prostate carcinoma have a lower quality of life (QOL) compared with men who have hormone‐sensitive prostate carcinoma and that quality of life (QOL) steadily declines over the last year of life for men with prostate carcinoma. The primary purpose of the current study was to evaluate whether there was evidence of palliative effects associated with suramin at any of the three doses administered in the original clinical trial.

Phase II study of carboxyamidotriazole in patients with advanced renal cell carcinoma refractory to immunotherapy : E4896, an eastern cooperative oncology group study

The current study evaluated the response rate and 6‐month time to disease progression of the antiangiogenesis agent carboxyamidotriazole (CAI) in patients with metastatic renal cell carcinoma (RCC).

A Phase II Study of 13-cis Retinoic Acid Plus Interferon α-2a in Advanced Stage Penile Carcinoma: An Eastern Cooperative Oncology Group Study (E3893)

Purpose. Combined biological therapy with 13-cis-retinoic acid (13-cRA) and interferon alpha-2a (IFN α-2a) was reported to be highly effective in squamous cell carcinoma of the cervix and skin. Squamous cell carcinoma of the penis is rare in the United States, accounting for less than1/2% of all male malignancies. Because of the association of infection with human papillomavirus with both carcinomas of the cervix and penis and their shared squamous cell histology, we carried out a phase II study of 13-cRA and IFN α-2a in carcinoma of the penis. Materials and Methods. Eighteen ambulatory patients with surgically unresectable, recurrent, and/or metastatic squamous cell carcinoma of the penis were treated with IFN α-2a, 3 MU/day administered subcutaneously and 13-cRA, l mg/kg orally daily for at least eight weeks, unless intolerable toxicity occurred. Results. One patient was ineligible; one patient withdrew prior to treatment. Among the 16 eligible, treated patients, there was one complete response. Fourteen patients had progressive disease as their only treatment effect. Two patients were unevaluable for tumor response because they had no follow-up tumor measurements. No unexpected treatment-related toxicities were found on study. The only common form of grade 3 toxicity was hypertriglyceridemia found in eight of the 17 patients (47%). No toxicities above grade 3 were observed. Conclusion. In contrast to its benefit in squamous cell carcinomas of the cervix and skin, the combination of 13-cRA and IFN α-2a has low efficacy in advanced carcinoma of the penis.

A phase Ib/II trial of granulocyte-macrophage-colony stimulating factor and interleukin-2 for renal cell carcinoma patients with pulmonary metastases: A case of fatal central nervous system thrombosis

Interleukin‐2 (IL‐2) and granulocyte‐macrophage−colony stimulating factor (GM‐CSF) are cytokines with nonoverlapping pleiotropic effects. In a prior Phase Ib study, this combination of agents exhibited antitumor effects in the lungs of four of eight patients with renal cell carcinoma and pulmonary metastases. We conducted this Phase Ib/II trial to determine the response rate of renal cell carcinoma patients with pulmonary metastases treated with continuous infusion IL‐2 plus GM‐CSF.

Overview of advanced urothelial cancer trials of the Eastern Cooperative Oncology group

Advanced transitional cell carcinoma of the urothelium is an aggressive malignancy characterized by a median survival period of less than 1 year. Although this disease is moderately chemotherapy‐sensitive, to the authors knowledge the impact of therapy reported to date on survival has been minimal. The authors presented an overview of the results from a series of clinical trials conducted over a 25‐year period under the auspices of the Eastern Cooperative Oncology Group. They reviewed a series of antineoplastic agents identified by these studies with activity in advanced urothelial cancer and discussed current and future investigational goals and directions. Cancer 2003;97(8 Suppl):2109–14.