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Trial Title:
Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer
NCT ID:
NCT01348009
Condition:
Gastric Carcinoma
Conditions: Official terms:
Stomach Neoplasms
Cisplatin
Capecitabine
Conditions: Keywords:
Gastric cancer
First-line therapy
Tesetaxel
Taxane
Capecitabine
Oral fluoropyrimidine
Cisplatin
Platinum
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tesetaxel-capecitabine-cisplatin
Description:
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.
Arm group label:
Tesetaxel-capecitabine-cisplatin
Other name:
DJ-927
Other name:
Xeloda
Other name:
CDDP
Other name:
Platinol
Other name:
Platinol-AQ
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yonsei Cancer Center, Yonsei University College of Medicine
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sun Young Rha, MD
Phone:
82-2-2228-8050
Investigator:
Last name:
Sun Young Rha, MD, PhD
Email:
Principal Investigator
Start date:
May 2011
Completion date:
January 2014
Lead sponsor:
Agency:
Genta Incorporated
Agency class:
Industry
Source:
Genta Incorporated
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01348009
