Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Oxaliplatin

Tegafur

Leucovorin

Levoleucovorin

Calcium

Calcium, Dietary

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

S-1, oral Leucovorin, Oxaliplatin

Narikazu Boku, MD

Introduction:

S-1 is promising drug which could replace 5-fluorouracil plus l-leucovorin (5-FU/l-LV) in treatment of advanced colorectal cancer.

Phase I/II study of S-1 plus Oxaliplatin (SOX) demonstrated its promising activity with acceptable toxicity as first-line chemotherapy in patients with untreated metastatic colorectal cancer and S-1 showed equivalent possibility to 5-FU/l-LV. On the other hand, phase I/II study of S-1 plus oral Leucovorin (S-1/LV) demonstrated that this regimen had enhanced efficacy in comparison with S-1 alone. From these results, it was expected that S-1/LV plus Oxaliplatin (SOL) would be more effective than SOX.

Therefore, phase I/II study of SOL combination therapy was planned.

Purpose A dose-finding study of S-1/LV plus Oxaliplatin (SOL) was planned to determine the recommended dose (RD), and to assess the response rate (RR) in patients with untreated metastatic colorectal cancer. The primary endpoints of the phase I portion are determination of the RD of SOL, and safety.

The phase II portion of this study was aimed to assess the RR of SOL.

Phase I/II Study of SOL for Untreated Metastatic Colorectal Cancer

Phase I/II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) in Patients With Untreated Metastatic Colorectal Cancer

Shizuoka Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I/II Study of SOL for Untreated Metastatic Colorectal Cancer	NCT00524706	Colorectal Canc...	S-1, oral Leuco...	20 Years - 74 Years	Shizuoka Cancer Center
Phase I/II Study of SOL for Untreated Metastatic Colorectal Cancer	NCT00524706	Colorectal Canc...	S-1, oral Leuco...	20 Years - 74 Years	Shizuoka Cancer Center

Spots Global Cancer Trial Database for oteracil potassium