FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer

Gastric Cancer Clinical Trial

Official title:

Phase II Study of FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913639
• Other study ID #: 13-080
• Status: Completed
• Phase: Phase 2
• Start date: July 2013
• Est. completion date: June 2019

Study information

• Verified date: June 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects, good and/or bad, of the drug regorafenib with chemotherapy regime (FOLFOX). This is a a Phase II trial that will study if this new treatment is effective and safe in patients with esophagus and stomach cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must have histologically or cytologically confirmed metastatic or unresectable esophageal, gastroesophageal junction or gastric adenocarcinoma.

• Patient must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease. Minimum indicator lesion size = 10 mm by helical CT or = 20 mm by conventional techniques. Pathological nodes must be = 15 mm by the short axis to be considered measurable.

• Subject must be able to swallow and retain oral medication

• Age 18 years or older.

• Karnofsky performance status > or = to 70%

• Peripheral neuropathy = grade 1

• Hematologic (minimal values) White blood cell count > or = to 3000/mm3© Absolute neutrophil count > 1500 cells/ mm3 Hemoglobin > or = to 8.0 g/dl Platelet count > or = to 90,000 / mm3 Total bilirubin = 1.5 x the upper limits of normal (ULN)

• Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) = 2.5 x ULN (= 5 x ULN for subjects with liver involvement of their cancer)

• Alkaline phosphatase limit = 2.5 x ULN (= 5 x ULN for subjects with liver involvement of their cancer). Patients with alkaline phosphatase elevation secondary to the bony metastases rather than liver dysfunction may proceed with treatment on protocol after discussion with the principal investigator.

• Serum creatinine = 1.5 x the ULN

• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test..

• Patients with prior deep vein thrombosis (DVT) or pulmonary embolism (PE) currently on an stable anticoagulation regimen with low molecular weight heparin (LMWH) or rivaroxaban will be permitted.

Exclusion Criteria:

• Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg on repeated measurement) despite optimal medical management.

• Active or clinically significant cardiac disease including:

• Congestive heart failure - New York Heart Association (NYHA) > Class II.

• Active coronary artery disease.

• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.

• Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.

• Evidence or history of bleeding diathesis or coagulopathy.

• Any hemorrhage or bleeding event = NCI CTCAE version 4.0 Grade 3 within 4 weeks prior to start of study medication.

• Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study.

• Active hepatitis B infection, active hepatitis C infection or known HIV carrier.

• Patient may not have received prior chemotherapy for metastatic or unresectable disease.

• Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration.

• Patient may not have received prior 5-Fluorouracil, Leucovorin, Oxaliplatin or regorafenib. Patient may have received prior radiosensitizing doses of 5Fu if more than 6 months have elapsed between the end of adjuvant therapy and registration.

• Patient may not have had major surgical procedure within 4 weeks of registration.

• Patient may not have had radiation within 2 weeks of registration.

Related Conditions & MeSH terms

• Esophageal Cancer
• Gastric Cancer

Intervention

Drug:
• Regorafenib

• 5-Fluorouracil

• Leucovorin

• Oxaliplatin

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering at Mercy Medical Center	Rockville Centre	New York
United States	Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital	Sleepy Hollow	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		6 months
Secondary	Overall Survival (OS)	Overall survival will be measured from the start of treatment to death or last follow-up and will be estimated using the Kaplan-Meier method	2 years
Secondary	Overall Response Rate	This is defined as the percentage of patients who have achieved either an objective complete or partial target lesion response that is confirmed on the RECIST 1.1 criteria. Complete or partial responses will be confirmed with repeat CT evaluation after 4 weeks.	4 weeks
Secondary	Participants Evaluated for Toxicity	Adverse events will be determined as per the NCI Common Toxicity Criteria, version 4.0. Toxicity during cycle 1 and subsequent cycles will be reported.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center