Use of picoplatin to treat colorectal cancer
View Patent ↗The invention provides a method of treatment of colorectal cancer by administration of the anti-cancer platinum drug picoplatin in conjunction with 5-FU and leucovorin in a variety of treatment regimens.
1. A method of treatment of colorectal cancer, comprising:
administering to a patient afflicted with colorectal cancer effective amounts of a combination of picoplatin, 5-fluorouracil (5-FU) and leucovorin, wherein the picoplatin, 5-FU and leucovorin are administered intravenously at least twice at intervals of about two weeks, wherein the amount of picoplatin is about 40-60 mg/m 2 every two weeks.
2. The method of claim 1 wherein the patient has not previously been treated for metastatic disease.
3. The method of claim 2 wherein the patient has not previously been treated systemically for metastatic disease.
4. The method of claim 1 wherein the colorectal cancer comprises metastatic sites.
5. The method of claim 4 wherein the treatment is curative of colorectal cancer metastases.
6. The method of claim 1 wherein the primary tumor is resected or debulked following administration of the picoplatin, the 5-FU and the leucovorin.
7. The method of claim 1 wherein the patient has previously had surgery to resect or de-bulk a colorectal tumor.
8. The method of claim 1 wherein the administration is effective to prevent or delay development or metastasis of the colorectal cancer.
9. The method of claim 1 wherein the picoplatin, when administered, and the leucovorin are administered substantially concurrently.
10. The method of claim 1 wherein the picoplatin, when administered, and the leucovorin are administered simultaneously.
11. The method of claim 1 wherein the 5-FU is administered following the administration of the picoplatin and the leucovorin.
12. The method of claim 1 wherein the leucovorin is administered at a dosage of about 400 mg/m 2 .
13. The method of claim 1 wherein the 5-FU is administered at a total dosage per dosing of about 2000-3000 mg/m 2 .
14. The method of claim 1 wherein the picoplatin is administered at a cumulative dosage of at least about 900 mg.
15. The method of claim 14 wherein the picoplatin is administered at a cumulative dosage of about 900-2000 mg/m 2 .
16. The method of claim 1 wherein the picoplatin is administered at least once at a dosage of about 40-45 mg/m 2 .
17. The method of claim 1 further comprising administration of a 5-HT 3 receptor antagonist.
18. The method of claim 1 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.