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Claims for Patent: 6,794,370

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Claims for Patent: 6,794,370

Title: Method for treating cancer using camptothecin derivatives and 5-fluorouracil
Abstract:A combination therapy for treating cancer including administering at least one camptothecin derivative in conjunction with another anticancer agent. The combination therapy is preferably used as a first-line therapy for treating metastatic colorectal cancer and preferably involves administration of a combination of CPT-11, 5-fluorouracil and folinic acid, according to specific infusional treatment schedules which show therapeutic synergy in the treatment of cancer.
Inventor(s): Achterrath; Wolf R. (Dectzenbach, DE)
Assignee: Aventis Pharma S.A. (Antony Cedex, FR)
Application Number:10/124,458
Patent Claims: 1. A method for treating cancer comprising administration of a combination of at least one camptothecin derivative, 5-fluorouracil (5-FU) and folinic acid to a host in need thereof in an amount and in a schedule of administration that is therapeutically synergistic in the treatment of said cancer.

2. The method of claim 1 wherein the administration of the combination is by infusion.

3. The method according to claim 1, wherein said schedule comprises a cycle of: administering FA 500 mg/m.sup.2 i.v. over 2 hours followed by the administration of 5-FU (from 2300 to 2600 mg/m.sup.2) i.v. and 80 mg/m.sup.2 of CPT-11 over 24 hours, once a week for 6 weeks, followed by a one week rest; and repeating said cycle until a progression or an unacceptable toxicity is observed.

4. The method according to claim 3, wherein said method is a first-line therapy for metastatic colorectal cancer.

5. The method according to claim 1, wherein said schedule comprises administering a two-week cycle wherein: 200 mg/m.sup.2 of folinic acid is administered i.v. over two hours on days one and two of said two-week cycle, 400 mg/m.sup.2 of 5-FU is administered by i,v, bolus on day one of said two-week cycle and 600 mg/m.sup.2 of said 5-FU is administered i.v. over 22 hours on day one of said two-week cycle, and 180 mg/m.sup.2 of CPT-11 is administered i.v. on day one of said two week cycle; and said two-week cycle is repeated until a progression or an unacceptable toxicity is observed.

6. The method according to claim 5, wherein said method is a first-line therapy for metastatic colorectal cancer.

7. The method according to claim 1, wherein said at least one camptothecin derivative is administered orally at the dose of from about 60 to 70 mg/m.sup.2 daily for five consecutive days, said schedule of CPT-11 administration being reproduced every three weeks.
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