Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

Launched by GENTA INCORPORATED · May 3, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Primary 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
• Primary 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