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Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer
Conditions
Gastric Carcinoma
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric cancer, First-line therapy, Tesetaxel, Taxane, Capecitabine, Oral fluoropyrimidine, Cisplatin, Platinum
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Tesetaxel-capecitabine-cisplatin
Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
- 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
Location
Yonsei Cancer Center, Yonsei University College of Medicine
Seoul, Korea, Republic of
Status: Recruiting
Contact: Sun Young Rha, MD - 82-2-2228-8050
Start Date
May 2011
Completion Date
January 2014
Sponsors
Genta Incorporated
Source
Genta Incorporated
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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