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The use of cisplatin in the treatment of 40 patients with metastatic soft tissue sarcoma was evaluated. The need for better chemotherapeutic approaches to soft tissue sarcoma is great, since the majority of patients with metastases (spreading of the cancer) eventually die from this disease. Cisplatin was chosen for this study because a clear dose-response relationship has been observed with the use of this drug in the treatment of other malignancies, and it was established that a 200 mg dose per meter squared could be given without significant kidney toxicity. The patients received the cisplatin dose over a five-day period, and cycles of chemotherapy were repeated at three or four week intervals. The suppression of bone marrow was moderately severe, and neurotoxicity was observed in 11 patients. Of the 40 patients, six achieved a partial response; of these six, all had a maximum of one previous course of chemotherapy; none achieved a complete response. Cisplatin has serious toxicity, and did not prove to be an effective treatment for metastatic soft tissue sarcoma. (Consumer Summary produced by Reliance Medical Information, Inc.)

A Phase I study using weekly docetaxel and gemcitabine was conducted to investigate toxicity; to determine the maximum tolerated dose (MTD) of each agent; and, in a preliminary fashion, to determine the antitumor activity of the combination. Docetaxel and gemcitabine were administered intravenously on Days 1, 8, and 15 every 28 days. The dose levels of docetaxel and gemcitabine were as follows: Level I, docetaxel 20 mg/m²and gemcitabine 400 mg/m²; Level II, docetaxel 30 mg/m²and gemcitabine 400 mg/m²; Level III, docetaxel 30 mg/m²and gemcitabine 600 mg/m²; Level IV, docetaxel 36 mg/m²and gemcitabine 600 mg/m²; and Level V, docetaxel 36 mg/m²and gemcitabine 800 mg/m². Thirty-three eligible patients were entered. The diagnoses were as follows: Eleven patients had nonsmall cell lung carcinoma, 3 patients had carcinoma of the bladder, 3 patients had renal carcinoma, 2 patients had adrenal carcinoma, 5 patients had unknown primary tumors, and 9 patients had miscellaneous malignancies. Fifty-nine percent of patients had received prior chemotherapy. The median age was 62 years (range, 27–77 years), and the median Eastern Cooperative Oncology Group performance status was 1 (range, 0–1). Five patients were treated at Dose Levels I and II, 6 patients were treated at Dose Levels III and V, and 11 patients were treated at Dose Level IV. Grade 3–4 toxicities during Cycle I included neutropenia, thrombocytopenia, mucositis, and diarrhea. Dose-limiting toxicity, consisting of neutropenia and thrombocytopenia, occurred in three of six patients at Dose Level V. The combination of docetaxel 36 mg/m² and gemcitabine 600 mg/m² (Dose Level IV) was determined as the MTD and was the recommended Phase II dose. Two patients had a partial response: one patient with bladder carcinoma (Dose Level II) and one patient with nonsmall cell lung carcinoma (Dose Level III). Overall, weekly docetaxel and gemcitabine were well tolerated. Further studies using this combination are planned, including a Phase II trial in patients with advanced nonsmall cell lung carcinoma. Cancer 2003;97:170–8. © 2003 American Cancer Society. DOI 10.1002/cncr.10991