Sorafenib Trial in Advanced and/or Recurrent Gastric Adenocarcinoma: Treatment Evaluation: STARGATE

NCT01187212 | Completed Phase 2

• 1 other identifier: AMC1002
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the efficacy and safety profiles of sorafenib in combination of capecitabine and cisplatin, one of standard chemotherapy regimens in patients with advanced gastric cancer.

Conditions

Malignant Neoplasm of Stomach; Effects of Chemotherapy

Keywords

First line chemotherapy in advanced gastric cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  2 years

Secondary Outcomes (8)

• Overall survival

  3 years

• Best tumor response

  2 years

• Duration of response

  2 years

• Disease control rate

  2 years

• Safety profiles

  up to 2years

Study Arms (2)

Capecitabine/Cisplatin

ACTIVE COMPARATOR

Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day (D) 1

Drug: Capecitabine/Cisplatin

Capecitabine/Cisplatin + Sorafenib

EXPERIMENTAL

Capecitabine 800 mg / m² po bid (D1-14) Cisplatin 60 mg / m² IV Day 1 Sorafenib 400 mg p.o. bid continuous dosing

Drug: Capecitabine/Cisplatin + Sorafenib

Interventions

Capecitabine/Cisplatin + Sorafenib DRUG

Capecitabine 800 mg / m² po bid (D1-14) Cisplatin 60 mg / m² IV Day 1 Sorafenib 400 mg p.o. bid continuous dosing

Also known as: Xeloda, Nexavar

Capecitabine/Cisplatin + Sorafenib

Capecitabine/Cisplatin DRUG

Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day 1

Also known as: Xeloda

Capecitabine/Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Histological or cytological documentation of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.;
• Metastatic gastric adenocarcinoma or metastatic gastroesophageal junction adenocarcinoma, initially diagnosed or recurrent.
• Measurable disease according to Response Evaluation Criteria in Solid Tumors
• ECOG Performance Status of 0 or 1
• Life expectancy of at least 3 months
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
• Hemoglobin ≥ 9.0 g / dl
• Absolute neutrophil count (ANC) ≥1,500 / mm3
• Platelet count ≥ 100,000 / mm3
• Total bilirubin \< 1.5 x upper limit of normal
• ALT and AST \< 2.5 x upper limit of normal (\< 5 x ULN for patients with liver involvement of their cancer)
• International normalized ratio of PT (PT-INR) / PTT \< 1.5 x ULN
• Creatinine Clearance ≥ 60 ml / min (based on Cockcroft and Gault formula)
• Ability to understand and willingness to sign a written informed consent. Signed informed consent must be obtained prior to any study specific procedures

You may not qualify if:

• Patients with local-regional gastric or gastroesophageal adenocarcinoma (no para-aortic nodes or visceral structure-invading primary \[T4\]) who can potentially become candidates for surgery with curative intent following systemic therapy
• History of cardiac disease:
• Congestive heart failure \>NYHA class 2; unstable angina (angina symptoms present at rest), new-onset angina (began within last three months prior to randomization) or myocardial infarction within six months prior to randomization;
• Ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted);
• Uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg) despite optimal medical management
• Past or concurrent history of neoplasm \< 5 years prior to start of study treatment other than gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix uteri or superficial bladder tumors \[Ta noninvasive tumor (Ta), carcinoma in situ (Tis) and T1 (tumor invades lamina propria)\]
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
• Evidence of gastrointestinal perforation or bowel obstruction during the screening period
• Evidence or history of bleeding diathesis or coagulopathy
• Non-healing wound, ulcer, or bone fracture
• History of gastrointestinal bleeding \> grade 1 CTCAE version 4.0 within 4 weeks prior to randomization
• History of any other bleeding \> grade 2 according to CTCAE version 4.0 within 4 weeks prior to randomization
• Known psychiatric and neurological disorders including known peripheral or autonomous neuropathy or hearing impairment \> grade 1 according to CTCAE version 4.0
• However, if the patient already has known irreversible grade 4 hearing loss (\>90 decibels (dB) bilaterally) at baseline, he or she is eligible at the investigator's discretion
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception \[Women of childbearing potential must have a negative serum pregnancy test performed within seven days prior to the start of treatment. Of note, both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and four weeks after the completion of trial or 6 months after last dose of cisplatin (whichever is greater). The definition of effective contraception will be based on the clinical judgment of the principal investigator or a designated associate.\]

Sponsors & Collaborators

• Asan Medical Center: lead
• Bayer: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

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MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Cisplatin; Sorafenib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Kang Yoon-Koo, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 24, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: August 1, 2014
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

KR (1)