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Gastric AdenocarcinomaPhase 2NCT00411151

Efficacy and Safety of Sunitinib in Metastatic Gastric Cancer

A Phase 2 study testing Sunitinib-Malate in people with Gastric Adenocarcinoma and Barrett Esophagus, run by Johannes Gutenberg University Mainz at 12 sites in Germany.

Completed

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

Official record
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Trial summary

This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer. Despite the efforts in front-line therapy, second-line protocols have not yet been established in randomized clinical trials for those… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Adenocarcinoma, Barrett Esophagus
What is being tested?
Sunitinib-Malate
Type of treatment
Pill or oral medicine
How many people
52 participants
Where
12 sitesGermany
Study dates
Dec 2006to Aug 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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)
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  • 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 trial
  • Pregnant or lactating women
  • Known allergic/hypersensitivity reaction to any of the components of the treatment; or known drug abuse/alcohol abuse

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • Charité, Campus Benjamin Franklin

    Berlin, State of Berlin, 12200

  • Universitätsklinik zu Köln, Klinik I für Innere Medizin

    Cologne, North Rhine-Westphalia, 50937

  • Universitätsklinikum Carl Gustav Carus, Med. Klinik I

    Dresden, Saxony, 01307

  • Universitätsklinikum der GHS Essen, Innere Klinik und Poliklinik, Tumorforschung

    Essen, North Rhine-Westphalia, 45122

  • KH Nordwest, Abteilung für Hämatologie und Onkologie

    Frankfurt, 60488

  • Universität Heidelberg, Nationales Zentrum für Tumorerkrankungen

    Heidelberg, Baden-Würtemberg, 69120

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, Saarland, 66421

  • Otto-von-Guericke-Universität Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

  • Klinikum der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • TU München, Klinikum rechts der Isar, II. Med. Klinik und Poliklinik

    München, Bavaria, 81675

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Würtemberg, 72076

  • Klinikum der Universität Würzburg

    Würzburg, Bavaria, 97070

Other trials in Germany

About this study

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

This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer. Despite the efforts in front-line therapy, second-line protocols have not yet been established in randomized clinical trials for those patients. Although many patients are still in good performance status and present with low tumor burden after failure of first-line chemotherapy, they may clearly benefit from second-line treatment. Increasingly more metachronic metastatic patients are urging for new platinum-free therapeutic options due to the fast-growing use of (neo-) adjuvant platin-based protocols.

So far, only sparse data on chemotherapy are available after failure of platin-based protocols. Nearly only irinotecan-containing combinations have properly been analyzed, and produced excellent response rates and survival times of up to 30% and 7.6 months, respectively. However, irinotecan has not been approved yet for this indication. In addition, as irinotecan-containing regimens have been submitted for approval for first-line therapy, second-line regimens in irinotecan-refractory patients have not been evaluated in any trial. Thus, there is an urgent need to establish new second-line treatment options for both, cisplatinum- or irinotecan-combination refractory patients with advanced or metastatic gastric cancer.

Sunitinib inhibits the receptor tyrosine kinases (RTKs) involved in tumor proliferation and angiogenesis, specifically the VEGFR, PDGFR, KIT, FLT-3, and RET. The VEGF pathway has been shown to be a significant factor in metastatic gastric cancer. In gastric carcinoma cells, VEGF ligands and its receptors are definitely involved in the process of tumor progression. KDR and FLT-1 are expressed widely and VEGF stimulated KDR-positive tumor cell growth directly. The ligand VEGF-C has also been shown to be involved in progression of human gastric carcinoma, particularly via lymphangiogenesis. In addition, peritoneal metastases of some cancers such as gastric cancers were largely dependent on VEGF. Therefore, patients with chemo-refractory metastatic gastric cancer might benefit from VEGFR inhibitory therapy with sunitinib.

Being tested
Sunitinib-Malate
Keywords
Adenocarcinoma of esophagogastric junction, Adenocarcinoma of lower esophagus (Barrett carcinoma)
Medical subject headings
Barrett Esophagus

What participants receive

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

  • Sunitinib-MalateDrug

    Capsules of 50, 25 or 12,5 mg. Dosage 50 mg, 37.5 mg or 25 mg once daily until progression of disease or untolerable side effects

What is being measured

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

  1. Objective Response Rate (ORR)

    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

    Measured: one year

Secondary outcomes (6)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from first dose of trial medication to first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

    Measured: one year

  2. Overall Survival (OS)

    OS is defined as the time from the first dose of trial medication to date of death due to any cause.

    Measured: one year

  3. One-Year Survival

    One-year survival is defined as the percentage of participants surviving for at least one year after first dose of trial medication.

    Measured: one year

  4. Adverse Events

    The number of participants with at least one adverse event was measured.

    Measured: one year

  5. Safety and Tolerability: Serious Adverse Events

    The number of participants with at least one Serious Adverse Event was measured.

    Measured: one year

  6. Safety and Tolerability: Adverse Events in ≥10% of Patients

    Measured: one year

Timeline

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

  1. First posted13 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionJul 2009
  4. Study completionAug 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00411151
Sponsor's protocol ID
GC-SU-2006
Other IDs
KKS 2005-015
Status last verified
Jan 2011
First submitted
11 Dec 2006
Last updated
20 Jan 2011
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib-Malate in people with Gastric Adenocarcinoma and Barrett Esophagus, run by Johannes Gutenberg University Mainz at 12 sites in Germany.

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 22 inclusion and 28 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 20 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. 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?

Yes. Results are posted in the registry (first posted 14 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) (time frame: one year). 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 NCT00411151.

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 20 Jan 2011.

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