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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01187212
First received: August 19, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Best tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety profiles [ Time Frame: up to 2years ] [ Designated as safety issue: Yes ]
    Toxicity profiles will be assessed with the patient 30 +/- 3 days after the last intake of study medication is required.

  • Best tumoral response of 2nd line sorafenib [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Best tumoral response of sorafenib in patients who progressed on capecitabine and cisplatin (control group)

  • Progression-free survival of 2nd line sorafenib [ Time Frame: 2years ] [ Designated as safety issue: No ]
    Progression-free survival of sorafenib in patients who progressed on capecitabine and cisplatin (control group)

  • Biomarker for sorafenib [ Time Frame: 2years ] [ Designated as safety issue: No ]
    Blood and tumor tissue will be collected during the study, and analyzed for biomarker at the end of trial.


Estimated Enrollment: 194
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187212

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

Publications:

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01187212     History of Changes
Other Study ID Numbers: AMC-ONCGI-1002
Study First Received: August 19, 2010
Last Updated: March 27, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
First line chemotherapy in advanced gastric cancer

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Sorafenib
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014