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

January 6, 2020 updated by: Yoon-Koo Kang, Asan Medical Center

A Randomized Phase II Study of Capecitabine and Cisplatin (XP) +/- Sorafenib (Nexavar®) in Patients With Advanced Gastric Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
3 years
Duration of response
Time Frame: 2 years
2 years
Disease control rate
Time Frame: 2 years
2 years
Best tumor response
Time Frame: 2 years
2 years
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.
up to 2years
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)
2 years
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)
2years
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.
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Bayer

Investigators

  • Principal Investigator: Kang Yoon-Koo, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (Estimate)

August 24, 2010

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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