Back to resultsTesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer
Primary Purpose
Gastric Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tesetaxel-capecitabine-cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Carcinoma focused on measuring Gastric cancer, First-line therapy, Tesetaxel, Taxane, Capecitabine, Oral fluoropyrimidine, Cisplatin, Platinum
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
Sites / Locations
- Yonsei Cancer Center, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tesetaxel-capecitabine-cisplatin
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival rate (in Phase 2 portion of study)
Secondary Outcome Measures
Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study)
The dose of tesetaxel in mg/m2 will be determined for Phase 2 based on the occurrence of dose-limiting toxicities in Phase 1.
Response rate, as defined in revised RECIST (in Phase 2 portion of study)
Duration of response (in Phase 2 portion of study)
Rate of responses at least 3 months in duration (in Phase 2 portion of study)
Disease control rate, which is defined as the percentage of patients with a response of any duration or stable disease at least 6 weeks in duration (in Phase 2 portion of study)
Durable response rate, which is defined as the percentage of patients with a response at least 6 months in duration (in Phase 2 portion of study)
Progression-free survival (in Phase 2 portion of study)
Overall survival (in Phase 2 portion of study)
Percentage of patients with adverse events (in Phase 1 and Phase 2 portions)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01348009
Brief Title
Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer
Official Title
A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genta Incorporated
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Carcinoma
Keywords
Gastric cancer, First-line therapy, Tesetaxel, Taxane, Capecitabine, Oral fluoropyrimidine, Cisplatin, Platinum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tesetaxel-capecitabine-cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tesetaxel-capecitabine-cisplatin
Other Intervention Name(s)
DJ-927, Xeloda, CDDP, Platinol, Platinol-AQ
Intervention 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.
Primary Outcome Measure Information:
Title
Progression-free survival rate (in Phase 2 portion of study)
Time Frame
6 months from the date of first dose of study medication
Secondary Outcome Measure Information:
Title
Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study)
Description
The dose of tesetaxel in mg/m2 will be determined for Phase 2 based on the occurrence of dose-limiting toxicities in Phase 1.
Time Frame
Up to 21 days after first dose of study medication
Title
Response rate, as defined in revised RECIST (in Phase 2 portion of study)
Time Frame
Up to 12 months following the date of first dose of study medication
Title
Duration of response (in Phase 2 portion of study)
Time Frame
Up to 12 months following the date of first dose of study medication
Title
Rate of responses at least 3 months in duration (in Phase 2 portion of study)
Time Frame
Up to 12 months following the date of first dose of study medication
Title
Disease control rate, which is defined as the percentage of patients with a response of any duration or stable disease at least 6 weeks in duration (in Phase 2 portion of study)
Time Frame
Up to 12 months following the date of first dose of study medication
Title
Durable response rate, which is defined as the percentage of patients with a response at least 6 months in duration (in Phase 2 portion of study)
Time Frame
Up to 12 months following the date of first dose of study medication
Title
Progression-free survival (in Phase 2 portion of study)
Time Frame
Up to 12 months following the date of first dose of study medication
Title
Overall survival (in Phase 2 portion of study)
Time Frame
Up to 12 months following the date of first dose of study medication
Title
Percentage of patients with adverse events (in Phase 1 and Phase 2 portions)
Time Frame
Up to 30 days after the last dose of study medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Young Rha, MD, PhD
Organizational Affiliation
Yonsei Cancer Center, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei Cancer Center, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Young Rha, MD
Phone
82-2-2228-8050
First Name & Middle Initial & Last Name & Degree
Sun Young Rha, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer
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