Liposomal cisplatin combined with gemcitabine in pretreated advanced pancreatic cancer patients: a phase I-II study.

The present trial is a phase I-II study based on a new liposomal cisplatin (lipoplatin). Previous preclinical and clinical data (phase I pharmacokinetics) led to the investigation of a combined treatment modality involving lipoplatin and gemcitabine. The gemcitabine dose was kept standard at 1000 mg/m2 and the lipoplatin dose was escalated from 25 mg/m2 to 125 mg/m2. The treatment was administered to advanced pretreated pancreatic cancer patients who were refractory to previous chemotherapy which included gemcitabine. Lipoplatin at 125 mg/m2 was defined as dose limiting toxicity (DLT) and 100 mg/m2 as the maximum tolerated dose (MTD) in combination with 1000 mg/m2 of gemcitabine. Preliminary objective response rate data showed a partial response in 2/24 patients (8.3%), disease stability in 14 patients (58.3%) for a median duration of 3 months (range 2-7 months) and clinical benefit in 8 patients (33.3%). Liposomal cisplatin is a non-toxic alternative agent to bare cisplatin. In combination with gemcitabine, it has an MTD of 100 mg/m2 and shows promising efficacy in refractory pancreatic cancer.

A phase II study of capecitabine plus oxaliplatin (XELOX): a new first-line option in metastatic colorectal cancer.

BACKGROUND: Capecitabine and oxaliplatin are both effective and well-tolerated monotherapies for the treatment of advanced colorectal cancer (CRC). Oxaliplatin has also been shown to be very effective when combined with 5-FU/LV in the first-line setting. AIM OF THE STUDY: Assess the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with previously untreated advanced CRC. METHODS: Fifty-three patients with measurable disease received capecitabine 1,000 mg/m2 twice daily on d 1-14 and oxaliplatin 130 mg/m2 on d 1, every 3 wk. Of these, 52 were evaluable for safety and 49 for antitumor response. RESULTS: There was a low rate of grade 1/2 adverse events; grade 3/4 events included leukopenia (10%), neutropenia (6%), thrombocytopenia (2%), nausea/vomiting (4%), and diarrhea (4%). The overall response rate was 39% (95% CI, 25-54%) and median time to disease progression was 7.8 mo. CONCLUSIONS: XELOX is an active and well-tolerated first-line treatment for advanced CRC. Randomized phase III studies are ongoing to compare XELOX with FOLFOX in view of the comparable efficacy and safety but superior convenience of XELOX therapy.

Hormone refractory advanced prostate cancer treated with estramustine and paclitaxel combination.

BACKGROUND: The objective of the present study was to investigate the effectiveness of weekly paclitaxel administration in combination with oral estramustine in patients with prostate cancer refractory to hormonal manipulation. PATIENTS AND METHODS: Between 1999 and 2000, 41 patients were included in the study. All patients had disease progression while on treatment with LH-RH and antiandrogens. After being off hormonal therapy for at least 4 weeks, oral estramustine 520 mg twice daily and 60 minutes paclitaxel 60 mg/m2 once weekly, were administered. In total 152 courses were given (median 3.71). RESULTS: Toxicity was well-tolerated. The most common adverse effect was low-grade (I-II) neurotoxicity. Objective partial responses were observed in 9 (22%) patients; when PSA decrease was included the total number of responders was 25 (61%) patients. Median survival was 17 months (range 4-42+ months). CONCLUSION: Long-term median and overall survival was achieved in patients with prostate cancer refractory to hormonal treatment, with oral estramustine and weekly paclitaxel administration. Toxicity was acceptable.