Sorafenib Trial in Advanced and/or Recurrent Gastric Adenocarcinoma: Treatment Evaluation: STARGATE
NCT ID: NCT01187212
Last Updated: 2020-01-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
195 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-08-31
Study Completion Date
2014-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Malignant Neoplasm of Stomach
Effects of Chemotherapy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Capecitabine/Cisplatin
Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day (D) 1
Group Type
ACTIVE_COMPARATOR
Capecitabine/Cisplatin
Intervention Type
DRUG
Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day 1
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
Group Type
EXPERIMENTAL
Capecitabine/Cisplatin + Sorafenib
Intervention Type
DRUG
Capecitabine 800 mg / m² po bid (D1-14) Cisplatin 60 mg / m² IV Day 1 Sorafenib 400 mg p.o. bid continuous dosing
Interventions
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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
Intervention Type
DRUG
Capecitabine/Cisplatin
Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day 1
Intervention Type
DRUG
Other Intervention Names
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Xeloda
Nexavar
Xeloda
Eligibility Criteria
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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
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Bayer
INDUSTRY
Sponsor Role
collaborator
Asan Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Yoon-Koo Kang
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Kang Yoon-Koo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Site Status
Countries
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South Korea
References
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BACKGROUND
Wang G, Dong Z, Xu G, Yang Z, Shou C, Wang N, Liu T. The effect of antibody against vascular endothelial growth factor on tumor growth and metastasis. J Cancer Res Clin Oncol. 1998;124(11):615-20. doi: 10.1007/s004320050223.
Reference Type
BACKGROUND
Wang TB, Deng MH, Qiu WS, Dong WG. Association of serum vascular endothelial growth factor-C and lymphatic vessel density with lymph node metastasis and prognosis of patients with gastric cancer. World J Gastroenterol. 2007 Mar 28;13(12):1794-7; discussion 1797-8. doi: 10.3748/wjg.v13.i12.1794.
Reference Type
BACKGROUND
Whitaker GB, Limberg BJ, Rosenbaum JS. Vascular endothelial growth factor receptor-2 and neuropilin-1 form a receptor complex that is responsible for the differential signaling potency of VEGF(165) and VEGF(121). J Biol Chem. 2001 Jul 6;276(27):25520-31. doi: 10.1074/jbc.M102315200. Epub 2001 May 1.
Reference Type
BACKGROUND
Yamamoto S, Yasui W, Kitadai Y, Yokozaki H, Haruma K, Kajiyama G, Tahara E. Expression of vascular endothelial growth factor in human gastric carcinomas. Pathol Int. 1998 Jul;48(7):499-506. doi: 10.1111/j.1440-1827.1998.tb03940.x.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AMC1002
Identifier Type: -
Identifier Source: org_study_id
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