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AdenocarcinomaPhase 2SUN-CASENCT01020630

Sunitinib in Patients With Advanced Gastric Cancer and Treated With FOLFIRI

A Phase 2 study testing Sunitinib in people with Adenocarcinoma, run by PD Dr Markus Möhler at 16 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 as add-on therapy with a widely used second-line palliative FOLFIRI chemotherapy in patients with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus (mGC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma
What is being tested?
Sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
16 sitesGermany
Study dates
Nov 2009to Jul 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated informed consent before the start of specific protocol procedures
  • Histological proven gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction or lower esophagus
  • Failure of any prior chemotherapy (docetaxel and/or platinum-based chemotherapy); but patient has not previously received FOLFIRI treatment
  • Measurable metastatic disease according to the RECIST criteria patients aged 18 years and older
  • karnofsky index 100 - 70 %
  • Life expectancy > 12 weeks
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  • Adequate hematological, hepatic and renal functions
  • At least 3 weeks from previous docetaxel- and/or platinum-based chemotherapy
  • Recovery from hematological side effects (CTC grade <1) and non-hematological side effects (CTC grade=<1) of any prior therapy (except oxaliplatine induced neuropathy CTC grade =<2)

Who cannot join

  • History of another primary malignancy >3 years, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix
  • Any prior palliative radiotherapy of the target lesions
  • Concurrent treatment with any other medicinal anti-cancer therapy
  • Prior treatment with a VEGF, VEGFR or RTK inhibitor, or prior enrolment on this study
  • Known allergic/hypersensitivity reaction to any of the components of the treatment
  • Treatment with potent CYP3A4 inhibitor within 7 days of Sunitinib/placebo dosing or with potent CYP3A4 inducer within 12 days of Sunitinib/placebo dosing
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  • Other serious illness or medical conditions within the last 12 months prior to study drug administration: Unstable cardiac disease despite treatment; myocardial infarction within 12 months prior to study entry; congestive heart failure NYHA grade 3 and 4; Hypertension that cannot be controlled by medication ; ongoing cardiac dysrhythmias of NCI CTCAE grade >2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females; History of significant neurologic or psychiatric disorders including dementia or seizures; Active uncontrolled infection; History of clinically significant bleeding within the past 6 months, including hemoptysis or haematuria, or underlying coagulopathy; Active disseminated intravascular coagulation; Cerebrovascular accident including transient ischemic attack; Pulmonary embolus; Bowel obstruction or chronic diarrhoea, history or presence of inflammatory enteropathy or extensive intestinal resection; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrolment, unless affected area has been removed surgically
  • Known deficit in DPD
  • Hypercalcemia not controlled by bisphosphonates
  • Contraindications to the use of atropine
  • Pregnant or lactating women; female patients who are pregnant or lactating or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 3 months after discontinuing study treatment
  • Known drug abuse/alcohol abuse
  • Current, recent, or planned participation in an experimental treatment drug study other than this protocol
  • Major surgical procedure, open biopsy or significant traumatic injury within 4 weeks before starting treatment; anticipation of need for major surgical procedure (e.g. impending bowel obstruction) during the course of the study
  • History of other medical or psychiatric condition, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Germany16 sites

  • Gesundheitszentrum St. Marien

    Amberg, 92224

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Universitätsmedizin Berlin Charite

    Berlin, 13353

  • Evangelisches Krankenhaus Bielefeld

    Bielefeld, 33611

  • Universitätsklinikum Essen

    Essen, 45122

  • Kliniken Essen-Mitte

    Essen, 45136

  • Krankenhaus Nordwest

    Frankfurt, Germany, 60488

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06120

  • MVZ für Innere Medizin in Hamburg-Eppendorf

    Hamburg, 20249

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Klinikum Ludwigsburg Medizinische Klinik I

    Ludwigsburg, 71640

  • Universitätsmedizin Mainz, 1. Med. Klinik

    Mainz, Rhineland-Palatinate, 55131

  • Technische Universität München

    München, 81675

  • Universitätsklinikum Rostock Klinik für Innere Medizin

    Rostock, 18057

  • Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH

    Schweinfurt, 97422

  • Klinikum Weiden

    Weiden, 92637

Other trials in Germany

About this study

Official title: A Randomized, Placebo-controlled Phase II Trial Investigating SUNITINIB Versus Placebo in Patients With Chemorefractory Advanced Adenocarcinoma of the Stomach or Lower Esophagus Treated With Chemotherapy FOLFIRI

This trial will be conducted to evaluate the efficacy, safety and tolerability of SUNITINIB as add-on therapy with a widely used second-line palliative FOLFIRI chemotherapy in patients with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus (mGC).

There is a clear scientific rationale for the use of Sunitinib to treat patients with mGC. Despite recent therapeutic advances, the median overall survival (OS) in patients with mG is still ≤ 12 months. Therefore, newer agents with novel mechanisms of action are desperately needed for treatment of these patients.

Read the detailed description

In parallel to the efforts in front-line therapy, second-line protocols like irinotecan-based regimens have been established in clinical trials for those patients. As many patients are still in good performance status and present with low tumor burden after failure of first-line chemotherapy, they clearly benefit from second-line treatment.

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.

The safety and efficacy of Sunitinib as single agent for the treatment of mGC has been determined and support the proposed clinical study with FOLFIRI in combination with Sunitinib in the treatment of patients with mGC.

Patients included in this trial suffer from advanced or metastatic adenocarcinoma of stomach or lower esophagus. They have failed to respond at least to one standard palliative first-line therapy (based on docetaxel and/or cisplatin plus 5-FU). Irinotecan/FA/5-FU can be determined as one established second-line treatment to be available for these patients.

Taken together, treatment of those patients with Sunitinib combined with standard chemotherapy FOLFIRI offers the chance to benefit from a new innovative therapy with acceptable side effects.

Conditions
Adenocarcinoma
Being tested
Sunitinib, Placebo
Keywords
adenocarcinoma of stomach, adenocarcinoma of lower oesophagus, sunitinib, FOLFIRI
Medical subject headings
Adenocarcinoma

What participants receive

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

  • SunitinibDrug

    Also called Sutent

    Sunitinib will be orally administered at 25 mg once daily (in the morning without regards to meals) for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks.

  • PlaceboDrug

    Placebo will be orally administered once daily (in the morning without regards to meals) for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks.

Study groups in NCT01020630
Study groupRoleWhat they receive
SunitinibExperimental25 mg (2 capsules of 12.5 mg) for oral administration
Receives: Drug: Sunitinib
PlaceboPlacebo comparator2 capsules for oral administration
Receives: Drug: Placebo

What is being measured

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

  1. The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1.

    Measured: Average time period: up to one year (participants are followed until progression or death)

Secondary outcomes (2)

  1. Objective response rate (CR + PR) according to RECIST

    Measured: Average time period: up to one year (participants are followed until progression or death)

  2. Safety and tolerability

    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 posted25 Nov 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionNov 2012
  4. Study completionJul 2013

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01020630
Sponsor's protocol ID
2009-02-SUN-Case
Acronym
SUN-CASE
Status last verified
May 2014
First submitted
23 Nov 2009
Last updated
14 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Moehler M, Gepfner-Tuma I, Maderer A, Thuss-Patience PC, Ruessel J, Hegewisch-Becker S, Wilke H, Al-Batran SE, Rafiyan MR, Weissinger F, Schmoll HJ, Kullmann F, von Weikersthal LF, Siveke JT, Weusmann J, Kanzler S, Schimanski CC, Otte M, Schollenberger L, Koenig J, Galle PR. Sunitinib added to FOLFIRI versus FOLFIRI in patients with chemorefractory advanced adenocarcinoma of the stomach or lower esophagus: a randomized, placebo-controlled phase II AIO trial with serum biomarker program. BMC Cancer. 2016 Aug 31;16(1):699. doi: 10.1186/s12885-016-2736-9.

    PubMed 27582078

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Adenocarcinoma, run by PD Dr Markus Möhler at 16 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 9 inclusion and 15 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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. Some participants in this study may receive a placebo. 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?

The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1. (time frame: Average time period: up to one year (participants are followed until progression or death)). 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 NCT01020630, which also lists 1 linked publication.

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 14 May 2014.

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