Use of picoplatin to treat colorectal cancer

1. A method of treatment of colorectal cancer, comprising:

administering to a patient afflicted with metastatic colorectal cancer picoplatin, 5-fluorouracil (5-FU), and leucovorin, wherein 5-FU and leucovorin are administered intravenously at least twice at intervals of about 2 weeks and the picoplatin is administered at doses of about 60-180 mg/m 2 every other time that the fluorouracil and leucovorin are administered.

2. The method of claim 1 wherein the patient has not previously been treated for metastatic colorectal cancer.

3. The method of claim 1 wherein the picoplatin and the leucovorin are administered substantially concurrently.

4. The method of claim 3 wherein the picoplatin and the leucovorin are administered simultaneously.

5. The method of any one of claims 1 , 3 or 4 wherein the 5-FU is administered following the administration of the picoplatin and the leucovorin.

6. The method of claim 5 wherein the leucovorin is administered at a dosage of about 400 mg/m 2 .

7. The method of claim 5 wherein the 5-FU is administered at a total dosage per dosing of about 2000-3000 mg/m 2 .

8. The method of claim 7 wherein the picoplatin is administered at a dosage of about 120-180 mg/m 2 .

9. The method of claim 8 wherein a subsequent dose of picoplatin is administered at about a 15-30 mg/m 2 lower dose than a previous dose.

10. The method of claim 9 wherein the picoplatin is administered at least once at a dosage of about 150 mg/m 2 .

11. The method of claim 1 , wherein a cumulative dose of greater than about 900 mg/m 2 of picoplatin is delivered to the patient.

12. The method of claim 1 wherein the leucovorin, at a dosage of about 400 mg/m 2 , is administered as a 2 hour infusion, the administration of the leucovorin being followed by a 5-FU bolus at a dosage of about 400 mg/m 2 ; the 5-FU bolus being followed by 5-FU at a dosage of about 2,400 mg/m 2 administered as a 46 hour continuous infusion; wherein the leucovorin and the 5-FU are administered to the patient every 2 weeks and about 60-150 mg/m 2 of the picoplatin is administered to the patient with the leucovorin and the 5-FU every 4 weeks, wherein at least the initial dose of picoplatin is about 150 mg/m 2 .

13. The method of claim 1 wherein the leucovorin is administered at a dose of about 250-500 mg/m 2 , being followed by a dose of about 2,000-3,000 mg/m 2 5-FU; wherein the leucovorin and the 5-FU are administered to the patient every two weeks and about 120-150 mg/m 2 of the picoplatin is administered to the patient with the leucovorin and the 5-FU every 4 weeks.

14. The method of any one of claims 1 , 12 or 13 comprising administering the picoplatin in a dosage form comprising an isotonic solution comprising:

(a) water;

(b) a tonicity adjuster; and

(c) about 0.5 mg/mL dissolved picoplatin.