25 patients with metastatic colorectal carcinoma previously treated with 5-fluorouracil and folinic acid for advanced disease, were treated with mitomycin C 8 mg/m(2) i.v. bolus on day 1, adriamycin 40 mg/m(2) i.v. bolus on day 1, and lonidamine 150 mg per os t.i.d. starting one day before chemotherapy and stopping 2 days after the end of chemotherapy. Treatment was repeated every 4 weeks. All patients had previous surgery and systemic chemotherapy with 5-fluorouracil and folinic acid given as first line chemotherapy for metastatic tumor. Sites of disease included liver, lung, nodes, abdomen, and bone. All enrolled patients were evaluable for objective response. Only one patient, affected by rectal carcinoma, showed a partial response (4%) which lasted 5.8+ months. No complete response was seen. Stable disease was recorded in 4 cases (16%) with a mean duration of 4.6+ months. All remaining patients had progressive disease. Median overall survival was 8.7+ months. Toxicity was significant. Grade 3 thrombocytopenia was seen in 8 cases (32%), and grade 3 leukopenia in 5 cases (20%). Grade 3 vomiting was observed in 9 patients (36%). The combination of mitomycin C, adriamycin and lonidamine is not effective in the treatment of metastatic colorectal adenocarcinoma resistant to 5-fluorouracil-based chemotherapy. These data suggest that lonidamine is not able to potentiate antineoplastic activity of chemotherapeutic drugs in humans and its use in colorectal cancer should be avoided since it has no or little impact on response rate and survival.

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