Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

NCT ID: NCT01348009

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-01-31

Brief Summary

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.

Conditions

Gastric Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tesetaxel-capecitabine-cisplatin

Group Type: EXPERIMENTAL

Tesetaxel-capecitabine-cisplatin

Intervention Type: DRUG

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.

Interventions

Tesetaxel-capecitabine-cisplatin

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.

Intervention Type: DRUG

Other Intervention Names

DJ-927; Xeloda; CDDP; Platinol; Platinol-AQ

Eligibility Criteria

Inclusion Criteria

• At least 20 years of age
• Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma.
• Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
• Previously untreated, unresectable advanced (M0) or unresectable metastatic (M1) disease except for prior adjuvant (or neo-adjuvant) chemotherapy.
• ECOG performance status 0 or 1
• At least 4 weeks and recovery from effects of prior major surgery
• Adequate bone marrow, hepatic, and renal function

Exclusion Criteria

• Operable gastric or gastroesophageal-junction cancer
• Known brain metastasis
• Second cancer
• Previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in combination. (Previous adjuvant or neo-adjuvant monotherapy with capecitabine or S-1 or therapy with S-1 and cisplatin in combination or 5-FU and cisplatin in combination is allowed.)
• Uncontrolled diarrhea
• Nausea or vomiting for at least 3 consecutive days within the 14 days prior to registration despite the administration of standard antiemetic therapy
• Symptomatic peripheral neuropathy ≥ Grade 2
• Malabsorption syndrome or other disease that significantly affects gastrointestinal function
• Other uncontrolled systemic illness

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genta Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sun Young Rha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei Cancer Center, Yonsei University College of Medicine

Locations

Yonsei Cancer Center, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Sun Young Rha, MD

Role: primary

82-2-2228-8050

Other Identifiers

TOPK105

Identifier Type: -

Identifier Source: org_study_id