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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01187212
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : October 13, 2014
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Stomach Effects of Chemotherapy Drug: Capecitabine/Cisplatin + Sorafenib Drug: Capecitabine/Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Capecitabine and Cisplatin (XP) +/- Sorafenib (Nexavar®) in Patients With Advanced Gastric Cancer
Study Start Date : August 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Capecitabine/Cisplatin
Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day (D) 1
Drug: Capecitabine/Cisplatin
Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day 1
Other Name: Xeloda
Experimental: Capecitabine/Cisplatin + Sorafenib
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
Capecitabine 800 mg / m² po bid (D1-14) Cisplatin 60 mg / m² IV Day 1 Sorafenib 400 mg p.o. bid continuous dosing
Other Names:
  • Xeloda
  • Nexavar

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
  2. Best tumor response [ Time Frame: 2 years ]
  3. Duration of response [ Time Frame: 2 years ]
  4. Disease control rate [ Time Frame: 2 years ]
  5. Safety profiles [ Time Frame: up to 2years ]
    Toxicity profiles will be assessed with the patient 30 +/- 3 days after the last intake of study medication is required.

  6. Best tumoral response of 2nd line sorafenib [ Time Frame: 2 years ]
    Best tumoral response of sorafenib in patients who progressed on capecitabine and cisplatin (control group)

  7. Progression-free survival of 2nd line sorafenib [ Time Frame: 2years ]
    Progression-free survival of sorafenib in patients who progressed on capecitabine and cisplatin (control group)

  8. Biomarker for sorafenib [ Time Frame: 2years ]
    Blood and tumor tissue will be collected during the study, and analyzed for biomarker at the end of trial.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18-75
  2. Histological or cytological documentation of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.;
  3. Metastatic gastric adenocarcinoma or metastatic gastroesophageal junction adenocarcinoma, initially diagnosed or recurrent.
  4. Measurable disease according to Response Evaluation Criteria in Solid Tumors
  5. ECOG Performance Status of 0 or 1
  6. Life expectancy of at least 3 months
  7. 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
  8. Creatinine Clearance ≥ 60 ml / min (based on Cockcroft and Gault formula)
  9. Ability to understand and willingness to sign a written informed consent. Signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

  1. 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
  2. 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
  3. 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)]
  4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
  5. Evidence of gastrointestinal perforation or bowel obstruction during the screening period
  6. Evidence or history of bleeding diathesis or coagulopathy
  7. Non-healing wound, ulcer, or bone fracture
  8. History of gastrointestinal bleeding > grade 1 CTCAE version 4.0 within 4 weeks prior to randomization
  9. History of any other bleeding > grade 2 according to CTCAE version 4.0 within 4 weeks prior to randomization
  10. 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
  11. 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.]
  12. Evidence of infection (> grade 2 )
  13. History of HIV infection or chronic / active hepatitis B or C
  14. Evidence of brain metastasis. Patients with unexplained neurological symptoms will undergo a CT scan or MRI of the brain to exclude metastases.
  15. Seizure disorder requiring treatment with medications that affect CYP 3A4
  16. History of organ allograft
  17. Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes or excipients in the formulation given during the course of this trial
  18. Any condition that is unstable or could jeopardize the safety of the patient and his / her compliance in the study
  19. Inability to swallow or retain oral medications
  20. Any malabsorption condition that the investigator deems would jeopardize the absorption or pharmacokinetics of the study medication
  21. Uncorrected dehydration
  22. Known dihydropyrimidine dehydrogenase deficiency
  23. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  24. Evidence of thrombotic or embolic disease, including cerebrovascular accident, transient ischemic attacks, or pulmonary embolus within the past 6 months
  25. Any tumor with characteristics that the investigator deems unsuitable for potentially cytoreductive therapy due to likelihood of severe bleeding or perforation such as ulcerations or hemorrhage. Excluded therapies and medications
  26. Prior or concomitant systemic anticancer therapy including cytotoxic therapy, targeted agents, or experimental therapy for gastric cancer. However, (neo)-adjuvant cytotoxic therapy is permitted if the last dose was administered > 6 months (12 months for platinum based therapy) before start of study medication in this study.
  27. Radiotherapy prior to or during the study (palliative radiotherapy will be allowed as described in the 'prior and concomitant therapy section',4.3.7)
  28. Use of biologic response modifiers, such as granulocyte G-CSF, within 3 weeks of study entry and during the study.
  29. Investigational drug therapy outside of this trial during or within 4 weeks prior to randomization
  30. Previous exposure to a Ras pathway inhibitor such MEK or Raf inhibitors or any farnesyl transferase inhibitors
  31. Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids

    • Low dose warfarin (1 mg p.o. q.d.) is permitted if the international normalized ratio is < 1.5
    • Low-dose aspirin is permitted (≤ 100 mg daily)
    • Prophylactic doses of heparin are permitted
    • For patients on warfarin, the INR will be measured prior to initiation of sorafenib, and patients will be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes as infrequent bleeding or elevations in the INR have been reported in some patients taking warfarin while on sorafenib therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01187212

Korea, Republic of
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: Kang Yoon-Koo, MD, PhD Asan Medical Center


Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center Identifier: NCT01187212     History of Changes
Other Study ID Numbers: AMC-ONCGI-1002
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
First line chemotherapy in advanced gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs