Clinical trial NCT01348009: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gastric Carcinoma
Keywords: Gastric cancer
First-line therapy
Tesetaxel
Taxane
Capecitabine
Oral fluoropyrimidine
Cisplatin
Platinum
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free survival rate (in Phase 2 portion of study)
timeFrame: 6 months from the date of first dose of study medication
Secondary outcomes:
measure: Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study)
timeFrame: Up to 21 days after first dose of study medication
measure: Response rate, as defined in revised RECIST (in Phase 2 portion of study)
timeFrame: Up to 12 months following the date of first dose of study medication
measure: Duration of response (in Phase 2 portion of study)
timeFrame: Up to 12 months following the date of first dose of study medication
measure: Rate of responses at least 3 months in duration (in Phase 2 portion of study)
timeFrame: Up to 12 months following the date of first dose of study medication
measure: 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)
timeFrame: Up to 12 months following the date of first dose of study medication
measure: 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)
timeFrame: Up to 12 months following the date of first dose of study medication
measure: Progression-free survival (in Phase 2 portion of study)
timeFrame: Up to 12 months following the date of first dose of study medication
measure: Overall survival (in Phase 2 portion of study)
timeFrame: Up to 12 months following the date of first dose of study medication
measure: Percentage of patients with adverse events (in Phase 1 and Phase 2 portions)
timeFrame: Up to 30 days after the last dose of study medication
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center, Yonsei University College of Medicine
Study officials:
affiliation: Yonsei Cancer Center, Yonsei University College of Medicine
name: Sun Young Rha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: