Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Cisplatin

Taxane

Antimetabolites

Phase 1: Tesetaxel orally on Day 1 of each cycle at dose of 18, 21, 24, or 27 mg/m2. If no dose-limiting toxicity, at least 3 subjects will be treated at each dose level until the maximum tolerated dose or the maximum dose of 27 mg/m2 is reached. At each tesetaxel dose level, capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.

Phase 2: Tesetaxel orally on Day 1 of each cycle at dose determined in Phase 1. Capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.

Tesetaxel-capecitabine-cisplatin

Sun Young Rha, MD

Sun Young Rha, MD, PhD

Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer.

This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.

Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer

The dose of tesetaxel in mg/m2 will be determined for Phase 2 based on the occurrence of dose-limiting toxicities in Phase 1.

Genta Incorporated

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer

Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal; total 1 year) of S-1 at 80-120 mg/body/day according to body surface area (BSA)

Takeshi Nagayasu, MD. PhD.

The investigators confirm the feasibility of 1-year administration of oral fluoropyrimidine S-1 as an adjuvant chemotherapy for the patient who received complete resection of non-small cell lung cancer. The investigators presume they can achieve high completion rate with low toxicity.

Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal) of S-1 (FT, gineracil, oteracil potassium; Taiho Pharmaceutical, Tokyo, Japan) at 80-120 mg/body/day according to body surface area (BSA): BSA \<1.25 m2, 80 mg/day; BSA \>1.25 m2 but \<1.5 m2, 100 mg/day; and BSA \>1.5 m2, 120 mg/day. S-1 was administered orally, twice daily after meals, starting within 4 weeks after surgery.

A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer

Tomoshi Tsuchiya

Senior Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer	NCT01348009	Gastric Carcino...	Tesetaxel-capec...	20 Years -	Genta Incorporated
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
A Feasibility Study of Oral Adjuvant Chemotherapy With S-1	NCT01459185	Non-small Cell ...	S-1	20 Years - 79 Years	Nagasaki University

Spots Global Cancer Trial Database for oral fluoropyrimidine