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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

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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

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.

Inclusion Criteria:

- 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

- 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)

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Markus Moehler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johannes Gutenberg University Mainz, 1. Med. Klinik


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

November 2009

Completion Date:

November 2012

Related Keywords:

  • Adenocarcinoma
  • adenocarcinoma of stomach
  • adenocarcinoma of lower oesophagus
  • sunitinib
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous