Regorafenib and Cetuximab in Patients With Advanced Malignancy

Completed · Phase 1

Conditions studied: Advanced Cancers

In brief

The goal of this clinical research study is to find the highest tolerable dose of the combination of regorafenib and cetuximab that can be given to patients with advanced solid tumors. The safety and effectiveness of this drug combination will also be studied.

Key facts

Study ID

NCT02095054

Run by

M.D. Anderson Cancer Center

People needed

39

Starts

2014-03-19

Expected to finish

2020-03-27

Last updated by the study team

2021-04-01

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be >= 12 years of age and > 40kgs.
• Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
• Patients must have evaluable or measurable disease by RECIST criteria for solid tumors.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients must be >/= 4 weeks beyond treatment with any chemotherapy or radiotherapy, and must have recovered to </= grade 2 toxicity for any treatment-limiting toxicity of prior therapy. (Exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, ribs, sternum, scapulae, vertebrae or skull were not included in the radiotherapy field). Also, patients who have received non-chemotherapeutic biologic agents will need to wait at least five half-lives or four weeks, whichever is shorter, from the last day of treatment. Exception: No washout of cetuximab or regorafenib is required for patients who have received prior cetuximab or regorafenib and have recovered from any treatment-related toxicities to Grade </= 1.
• ECOG performance status </= 2 (Karnofsky >/= 60%).
• Patients must have: leukocytes >/= 3,000/mL; absolute neutrophil count >/= 1,000/mL; platelets >/=100,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 3 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; AST (SGOT) and ALT(SGPT) </= 5 X ULN. Patients should not have received any platelet transfusions in the last 4 weeks before screening date.
• Patients should not become pregnant or breastfeed while on this study. Sexually active patients must agree to use contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose.

You may not qualify if…

• KRAS mutated colorectal cancer.
• Major surgery within 28 days prior to the first dose of study medication.
• Pregnant or lactating women.
• Patients with hemoptysis within 28 days prior to entering the study.
• Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.
• Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
• Patients with clinically significant cardiovascular disease: 1). History of CVA within 6 months; 2). Myocardial infarction or unstable angina within 6 months; 3). Unstable angina pectoris; 4). New York Heart Association Class III or greater congestive heart failure.
• Patients with untreated or progressing brain metastases.
• Patients who had radiation to greater than 25% marrow in the past 5 years.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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