Clinical trial NCT01260194: A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
Official title: An Open-label, Multicentre Phase IV Study of Trastuzumab in Combination With the Standard Therapy (as Per Routine Clinical Practice) as First-line Therapy in Patients With HER2 Positive Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
* HER2 positive tumor (primary tumor or metastasis
* ECOG Performance status 0, 1 or 2
* Life expectancy of at least 3 months

Exclusion Criteria:

* Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
* Patients with active (significant or uncontrolled) gastrointestinal bleeding
* Residual relevant toxicity resulting from previous chemotherapy
* Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)

Primary outcomes:
measure: Median Progression Free Survival (PFS)
timeFrame: Baseline up to PD or death (maximum up to 22 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline up to death (maximum up to 22 months)
measure: Percentage of Participants With Overall Tumor Response
timeFrame: Baseline up to PD or death (maximum up to 22 months)
measure: Percentage of Participants With Clinical Benefit Response (CBR)
timeFrame: Baseline up to PD or death (maximum up to 22 months)
measure: Duration of Response (DR)
timeFrame: Baseline up to PD or death (maximum up to 22 months)
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 6 month after last dose of study drug (maximum up to 22 months)
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
timeFrame: Baseline up to 6 month after last dose of study drug (maximum up to 22 months)
measure: Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline, thereafter every 12 weeks (maximum up to 22 months)
measure: Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer
timeFrame: Baseline
Other outcomes:
Locations:
city: New Delhi
country: India
state: Delhi
city: Bangalore
country: India
state: Karnataka
city: Bangalore
country: India
city: Nagpur
country: India
city: Noida
country: India
city: Vishakpatnam
country: India
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: