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Malignant Neoplasm of StomachPhase 2NCT01187212

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

A Phase 2 study testing Capecitabine/Cisplatin + Sorafenib and Capecitabine/Cisplatin in people with Malignant Neoplasm of Stomach and Effects of Chemotherapy, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Capecitabine/Cisplatin + Sorafenib and Capecitabine/Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
1 siteSouth Korea
Study dates
Aug 2010to Aug 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)]
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  • 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.]
  • Evidence of infection (> grade 2 )
  • History of HIV infection or chronic / active hepatitis B or C
  • Evidence of brain metastasis. Patients with unexplained neurological symptoms will undergo a CT scan or MRI of the brain to exclude metastases.
  • Seizure disorder requiring treatment with medications that affect CYP 3A4
  • History of organ allograft
  • 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
  • Any condition that is unstable or could jeopardize the safety of the patient and his / her compliance in the study
  • Inability to swallow or retain oral medications
  • Any malabsorption condition that the investigator deems would jeopardize the absorption or pharmacokinetics of the study medication
  • Uncorrected dehydration
  • Known dihydropyrimidine dehydrogenase deficiency
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Evidence of thrombotic or embolic disease, including cerebrovascular accident, transient ischemic attacks, or pulmonary embolus within the past 6 months
  • 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
  • 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.
  • Radiotherapy prior to or during the study (palliative radiotherapy will be allowed as described in the 'prior and concomitant therapy section',4.3.7)
  • Use of biologic response modifiers, such as granulocyte G-CSF, within 3 weeks of study entry and during the study.
  • Investigational drug therapy outside of this trial during or within 4 weeks prior to randomization
  • Previous exposure to a Ras pathway inhibitor such MEK or Raf inhibitors or any farnesyl transferase inhibitors
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: 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.

Being tested
Capecitabine/Cisplatin + Sorafenib, Capecitabine/Cisplatin
Keywords
First line chemotherapy in advanced gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capecitabine/Cisplatin + SorafenibDrug

    Also called Xeloda, Nexavar

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

  • Capecitabine/CisplatinDrug

    Also called Xeloda

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

Study groups in NCT01187212
Study groupRoleWhat they receive
Capecitabine/CisplatinActive comparatorCapecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day (D) 1
Receives: Drug: Capecitabine/Cisplatin
Capecitabine/Cisplatin + SorafenibExperimentalCapecitabine 800 mg / m² po bid (D1-14) Cisplatin 60 mg / m² IV Day 1 Sorafenib 400 mg p.o. bid continuous dosing
Receives: Drug: Capecitabine/Cisplatin + Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: 2 years

Secondary outcomes (8)

  1. Overall survival

    Measured: 3 years

  2. Best tumor response

    Measured: 2 years

  3. Duration of response

    Measured: 2 years

  4. Disease control rate

    Measured: 2 years

  5. Safety profiles

    Toxicity profiles will be assessed with the patient 30 +/- 3 days after the last intake of study medication is required.

    Measured: up to 2years

  6. Best tumoral response of 2nd line sorafenib

    Best tumoral response of sorafenib in patients who progressed on capecitabine and cisplatin (control group)

    Measured: 2 years

  7. Progression-free survival of 2nd line sorafenib

    Progression-free survival of sorafenib in patients who progressed on capecitabine and cisplatin (control group)

    Measured: 2years

  8. Biomarker for sorafenib

    Blood and tumor tissue will be collected during the study, and analyzed for biomarker at the end of trial.

    Measured: 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionNov 2013
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01187212
Sponsor's protocol ID
AMC1002
Status last verified
Jan 2020
First submitted
19 Aug 2010
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Ahn YO, Park BJ, Yoo KY, Kim NK, Heo DS, Lee JK, Ahn HS, Kang DH, Kim H, Lee MS, et al. Incidence estimation of stomach cancer among Koreans. J Korean Med Sci. 1991 Mar;6(1):7-14. doi: 10.3346/jkms.1991.6.1.7.

    PubMed 1888453

  • Bang YJ, Kang WK, Kang YK, Kim HC, Jacques C, Zuber E, Daglish B, Boudraa Y, Kim WS, Heo DS, Kim NK. Docetaxel 75 mg/m(2) is active and well tolerated in patients with metastatic or recurrent gastric cancer: a phase II trial. Jpn J Clin Oncol. 2002 Jul;32(7):248-54. doi: 10.1093/jjco/hyf057.

    PubMed 12324575

  • Borgstrom P, Gold DP, Hillan KJ, Ferrara N. Importance of VEGF for breast cancer angiogenesis in vivo: implications from intravital microscopy of combination treatments with an anti-VEGF neutralizing monoclonal antibody and doxorubicin. Anticancer Res. 1999 Sep-Oct;19(5B):4203-14.

    PubMed 10628376

  • Bremnes RM, Camps C, Sirera R. Angiogenesis in non-small cell lung cancer: the prognostic impact of neoangiogenesis and the cytokines VEGF and bFGF in tumours and blood. Lung Cancer. 2006 Feb;51(2):143-58. doi: 10.1016/j.lungcan.2005.09.005. Epub 2005 Dec 19.

    PubMed 16360975

  • Chong G, Cunningham D. Gastrointestinal cancer: recent developments in medical oncology. Eur J Surg Oncol. 2005 Jun;31(5):453-60. doi: 10.1016/j.ejso.2005.02.026. Epub 2005 Apr 13.

    PubMed 15922879

  • Constenla M, Garcia-Arroyo R, Lorenzo I, Carrete N, Campos B, Palacios P. Docetaxel, 5-fluorouracil, and leucovorin as treatment for advanced gastric cancer: results of a phase II study. Gastric Cancer. 2002;5(3):142-7. doi: 10.1007/s101200200025.

    PubMed 12378340

  • Einzig AI, Neuberg D, Remick SC, Karp DD, O'Dwyer PJ, Stewart JA, Benson AB 3rd. Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: the Eastern Cooperative Oncology Group (ECOG) results of protocol E1293. Med Oncol. 1996 Jun;13(2):87-93. doi: 10.1007/BF02993858.

    PubMed 9013471

  • Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997 Feb;18(1):4-25. doi: 10.1210/edrv.18.1.0287. No abstract available.

    PubMed 9034784

  • Graziano F, Catalano V, Baldelli AM, Giordani P, Testa E, Lai V, Catalano G, Battelli N, Cascinu S. A phase II study of weekly docetaxel as salvage chemotherapy for advanced gastric cancer. Ann Oncol. 2000 Oct;11(10):1263-6. doi: 10.1023/a:1008373814453.

    PubMed 11106114

  • Jain RK. Normalizing tumor vasculature with anti-angiogenic therapy: a new paradigm for combination therapy. Nat Med. 2001 Sep;7(9):987-9. doi: 10.1038/nm0901-987. No abstract available.

    PubMed 11533692

  • Kamiyama M, Ichikawa Y, Ishikawa T, Chishima T, Hasegawa S, Hamaguchi Y, Nagashima Y, Miyagi Y, Mitsuhashi M, Hyndman D, Hoffman RM, Ohki S, Shimada H. VEGF receptor antisense therapy inhibits angiogenesis and peritoneal dissemination of human gastric cancer in nude mice. Cancer Gene Ther. 2002 Feb;9(2):197-201. doi: 10.1038/sj.cgt.7700428.

    PubMed 11857038

  • Kanai T, Konno H, Tanaka T, Baba M, Matsumoto K, Nakamura S, Yukita A, Asano M, Suzuki H, Baba S. Anti-tumor and anti-metastatic effects of human-vascular-endothelial-growth-factor-neutralizing antibody on human colon and gastric carcinoma xenotransplanted orthotopically into nude mice. Int J Cancer. 1998 Sep 11;77(6):933-6. doi: 10.1002/(sici)1097-0215(19980911)77:63.0.co;2-0.

    PubMed 9714067

  • Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr;20(4):666-73. doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19.

    PubMed 19153121

  • Karayiannakis AJ, Syrigos KN, Polychronidis A, Zbar A, Kouraklis G, Simopoulos C, Karatzas G. Circulating VEGF levels in the serum of gastric cancer patients: correlation with pathological variables, patient survival, and tumor surgery. Ann Surg. 2002 Jul;236(1):37-42. doi: 10.1097/00000658-200207000-00007.

    PubMed 12131083

  • Kawasaki T, Kitsukawa T, Bekku Y, Matsuda Y, Sanbo M, Yagi T, Fujisawa H. A requirement for neuropilin-1 in embryonic vessel formation. Development. 1999 Nov;126(21):4895-902. doi: 10.1242/dev.126.21.4895.

    PubMed 10518505

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine/Cisplatin + Sorafenib and Capecitabine/Cisplatin in people with Malignant Neoplasm of Stomach and Effects of Chemotherapy, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01187212, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.

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