Sunitinib in Patients With Advanced Gastric Cancer and Treated With FOLFIRI (SUN-CASE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- 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) ] [ Designated as safety issue: No ]
- Objective response rate (CR + PR) according to RECIST [ Time Frame: Average time period: up to one year (participants are followed until progression or death) ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
25 mg (2 capsules of 12.5 mg) for oral administration
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.
Other Name: Sutent
Placebo Comparator: Placebo
2 capsules for oral administration
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.
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.
|Universitätsmedizin Mainz, 1. Med. Klinik|
|Mainz, Rheinland-Pfalz, Germany, 55131|
|Gesundheitszentrum St. Marien|
|Amberg, Germany, 92224|
|Helios Klinikum Berlin-Buch|
|Berlin, Germany, 13125|
|Universitätsmedizin Berlin Charite|
|Berlin, Germany, 13353|
|Evangelisches Krankenhaus Bielefeld|
|Bielefeld, Germany, 33611|
|Essen, Germany, 45136|
|Essen, Germany, 45122|
|Frankfurt, Germany, 60488|
|Halle, Germany, 06120|
|MVZ für Innere Medizin in Hamburg-Eppendorf|
|Hamburg, Germany, 20249|
|Universitätsklinikum des Saarlandes|
|Homburg, Germany, 66421|
|Klinikum Ludwigsburg Medizinische Klinik I|
|Ludwigsburg, Germany, 71640|
|Technische Universität München|
|München, Germany, 81675|
|Universitätsklinikum Rostock Klinik für Innere Medizin|
|Rostock, Germany, 18057|
|Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH|
|Schweinfurt, Germany, 97422|
|Weiden, Germany, 92637|
|Principal Investigator:||Markus Moehler, MD||Johannes Gutenberg University Mainz, 1. Med. Klinik|