Sunitinib in Patients With Advanced Gastric Cancer and Treated With FOLFIRI

NCT01020630 | Completed Phase 2 DMC

• 1 other identifier: 2009-02-SUN-Case
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 16

Brief 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). 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.

Conditions

Adenocarcinoma

Keywords

adenocarcinoma of stomach; adenocarcinoma of lower oesophagus; sunitinib; FOLFIRI

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (2)

• Objective response rate (CR + PR) according to RECIST

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

• Safety and tolerability

  one year

Study Arms (2)

Sunitinib

EXPERIMENTAL

25 mg (2 capsules of 12.5 mg) for oral administration

Drug: Sunitinib

Placebo

PLACEBO COMPARATOR

2 capsules for oral administration

Drug: Placebo

Interventions

Sunitinib DRUG

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.

Also known as: Sutent

Sunitinib

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• PD Dr Markus Möhler: lead

Study Sites (16)

Krankenhaus Nordwest

Frankfurt, Germany, 60488, Germany

Location

Universitätsmedizin Mainz, 1. Med. Klinik

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Gesundheitszentrum St. Marien

Amberg, 92224, Germany

Location

Helios Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Universitätsmedizin Berlin Charite

Berlin, 13353, Germany

Location

Evangelisches Krankenhaus Bielefeld

Bielefeld, 33611, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Kliniken Essen-Mitte

Essen, 45136, Germany

Location

Martin-Luther-Universität Halle-Wittenberg

Halle, 06120, Germany

Location

MVZ für Innere Medizin in Hamburg-Eppendorf

Hamburg, 20249, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Klinikum Ludwigsburg Medizinische Klinik I

Ludwigsburg, 71640, Germany

Location

Technische Universität München

München, 81675, Germany

Location

Universitätsklinikum Rostock Klinik für Innere Medizin

Rostock, 18057, Germany

Location

Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH

Schweinfurt, 97422, Germany

Location

Klinikum Weiden

Weiden, 92637, Germany

Location

Related Publications (1)

• 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.

  PMID: 27582078 DERIVED

MeSH Terms

Conditions

Adenocarcinoma

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Markus Moehler, MD

  Johannes Gutenberg University Mainz, 1. Med. Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: July 1, 2013
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

DE (16)