Status:
TERMINATED
A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy i...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least liver or lung or both
- Measurable disease according to RECIST Version 1.1 or non-measurable evaluable disease
- At least 2 organs involved in metastatic gastric tumor (including at least lung or liver or both) in addition to the site of primary tumor, where metastasis in distant lymph nodes, peritoneal metastasis, and malignant pleural effusion may count as "organs" in this context
- HER2-positive primary or metastatic tumor as assessed by central laboratory
- Adequate renal function (creatinine clearance greater than equal to (≥) 45 milliliters per minute \[mL/min\])
- Eastern Cooperative Oncology Group (ECOG) performance status of 2
Exclusion
- Previous chemotherapy for locally advanced or metastatic disease
- Prior gastrectomy (partial or total) for the underlying malignant disease under investigation
- Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
- Residual relevant toxicity resulting from previous therapy
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (such as jejunostomy probe and gastric or jejunostomy tubes) which may impair the ability to administer or absorb capecitabine
- Current (significant or uncontrolled) gastrointestinal bleeding
- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin
- History of documented congestive heart failure, angina pectoris requiring medication, electrocardiogram (ECG) evidence of transmural myocardial infraction, poorly controlled hypertension, clinically significant valvular heart disease, or high-risk uncontrollable arrhythmias
- Baseline left ventricular ejection fraction (LVEF) less than (\<) 50%, documented by echocardiography, multiple-gated radionuclide angiography (MUGA) scan, or cardiac magnetic resonance imaging (MRI)
- Chronic or high-dose corticosteroid therapy
- History or clinical evidence of brain metastases
- Pregnant women
- Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, or HIV-seropositive
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT01450696
Start Date
December 1 2011
End Date
August 1 2015
Last Update
November 28 2016
Active Locations (117)
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1
La Jolla, California, United States, 92093
2
Los Angeles, California, United States, 90033
3
Whittier, California, United States, 90603
4
Whittier, California, United States, 90606