Know Cancer

forgot password

An Open-label, Multicenter Phase II Trial of Sunitinib for Patients With Chemo-refractory Metastatic Gastric Cancer

Phase 2
18 Years
Not Enrolling
Gastric Adenocarcinoma, Barrett Esophagus

Thank you

Trial Information

An Open-label, Multicenter Phase II Trial of Sunitinib for Patients With Chemo-refractory Metastatic Gastric Cancer

Inclusion Criteria:

- Signed and dated informed consent of the patient before the start of specific
protocol procedures

- Histologically proven adenocarcinoma of stomach, esophagogastric junction or lower
esophagus (Barrett carcinoma)

- Measurable metastatic disease according to the Response Evaluation Criteria in Solid
Tumors (RECIST). If locally recurrent disease, it must be associated with at least
one measurable lymph node (> 20 mm by computed tomography [CT] scan or > 10 mm with
spiral CT).

- Failure of prior palliative chemotherapy/chemotherapies (at least one irinotecan- or
cisplatin-based). Failure is defined either by progression of disease or by
significant toxicity that precludes further treatment.

- At least 3 weeks from previous chemotherapy at first dose of trial drug

- Resolution of all acute toxic side effects of prior therapy or surgical procedures to
grade ≤ 1 National Cancer Institute-Common Toxicity Criteria (NCI-CTC) (except for
the laboratory values)

- Adequate organ function as defined by the following criteria:

- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase
[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase
[SGPT]) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver
function abnormalities are due to underlying malignancy

- Total serum bilirubin ≤ 1.5 x ULN

- Absolute neutrophil count (ANC) ≥1500/microL

- Platelets ≥ 100,000/microL

- Hemoglobin ≥ 8.0 g/dL without support of growth factors (previous administration
of erythrocyte concentrate is allowed)

- Serum calcium ≤ 12.0 mg/dL

- Serum creatinine ≤ 2.0 x ULN

- Lipase/amylase ≤ 2.5 x ULN

- All other laboratory values specified in the protocol (white blood cell count,
white blood cell differential, alkaline phosphatase, sodium, potassium,
creatinine clearance): resolution of all side effects of prior therapy or
surgical procedure to grade < 3 NCI-CTC

- At least 4 weeks from any major surgery (at first dose of trial drug)

- Karnofsky Performance Status (KPS) ≥ 70

- Life expectancy > 12 weeks

- Patients must be able to swallow sunitinib capsules

- Patients who understand the nature of the trial and are willing and able to comply
with scheduled visits, treatment plans, laboratory tests and other trial procedures

- Female patients who are capable of bearing children must have a negative pregnancy
test result (serum or urine) at trial entry. All women included in the trial must be
surgically sterile or postmenopausal or agree to employ adequate birth control
measures for the duration of the trial and six months post-dosing. Male patients must
be surgically sterile or must agree to use effective contraception during the trial
and six months post-dosing.

Exclusion Criteria:

- Tumor type other than adenocarcinoma (e.g., leiomyosarcoma, lymphoma) or a second
cancer except in patients with squamous or basal cell carcinoma of the skin or
carcinoma in situ of the cervix which has been effectively treated. Patients
curatively treated and disease free for at least 5 years will be discussed with the
sponsor before inclusion.

- Patients with known brain or leptomeningeal metastasis

- Intake of non-permitted concomitant drugs. (The coordinating investigator should be
contacted to discuss the individual case.)

- Concomitant treatment with antiarrhythmics and drugs with dysrhythmic potential
(i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol,
bepridil, haloperidol, risperidone, and indapamide)

- Administration of potent CYP34A inhibitors during or within 7 days before start
of sunitinib-treatment (e.g. ketoconazole, itraconazole, clarithromycin,
erythromycin, diltiazem, verapamil, delavirdine, indinavir, saquinavir,
ritonavir, atazanavir, nelfinavir, grapefruit juice)

- Administration of potent CYP3A4 inducers during or within 12 days before start
of sunitinib-treatment (e.g. dexamethasone, rifampicin, rifabutin,
carbamazepine, phenobarbital, phenytoin, St. John´s wort, efavirenz, tipranavir)

- Ongoing treatment with therapeutic doses of anticoagulants such as Coumadin or
heparins. (However, low dose Coumadin up to 2 mg by mouth [PO] daily for deep
vein thrombosis prophylaxis is allowed.)

- Any other medicinal anticancer therapy during treatment phase except treatment
with non-conventional therapies (e.g. herbs or acupuncture) and vitamins/mineral
supplements, provided that they do not interfere with the trial endpoint, in the
opinion of the investigator

- Concurrent systemic immune therapy, chemo- or hormone therapy

- Concomitant or within a 4-week period administration (from first dose of trial
drug) of any other experimental drug under investigation (except for irinotecan
and cetuximab) and participation in another clinical trial

- Any prior radiotherapy of target lesions

- Bowel obstruction, history or presence of inflammatory enteropathy or extensive
intestinal resection (> hemicolectomy or extensive small intestine resection with
chronic diarrhea), Crohn's disease, ulcerative colitis

- Current history of chronic diarrhoea

- Active disseminated intravascular coagulation, or patients prone to thromboembolism

- Any of the following events (in any grade) prior to starting the trial treatment:

- myocardial infarction

- severe/unstable angina

- coronary/peripheral artery bypass graft

- congestive heart failure

- cerebrovascular accident or transient ischemic attack

- pulmonary embolism

- Known history of QT interval prolongation, ongoing QT prolongation (> 450 msec for
males or > 470 msec for females), any cardiac ventricular dysrhythmias, atrial
fibrillation of any grade

- Hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal
medical therapy)

- Known human immunodeficiency virus (HIV) infection

- Active uncontrolled infection

- Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that would impart, in the judgment of the investigator, excess risk
associated with trial participation or trial drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry into the

- Pregnant or lactating women

- Known allergic/hypersensitivity reaction to any of the components of the treatment;
or known drug abuse/alcohol abuse

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (ORR)

Outcome Description:

The primary endpoint is the ORR within the first 6 treatment cycles, defined as the percentage of participants with a confirmed reduction in tumor size fulfilling the criteria for complete or partial response (CR or PR) according to RECIST. CR=disappearance of all target lesions, PR=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Markus Moehler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johannes-Gutenberg-University of Mainz, I. Dept. Internal Medicine


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

December 2006

Completion Date:

August 2009

Related Keywords:

  • Gastric Adenocarcinoma
  • Barrett Esophagus
  • Adenocarcinoma of esophagogastric junction
  • Adenocarcinoma of lower esophagus (Barrett carcinoma)
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Barrett Esophagus
  • Stomach Neoplasms