Recruitment

Recruitment Status
Completed
Estimated Enrollment
83

Inclusion Criteria

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.
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 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 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.
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 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.
Ability to understand and the willingness to sign a written informed consent document.
ECOG performance status </= 2 (Karnofsky >/= 60%).
Patient must be >= 12 years of age and > 40kgs.
Patients must have evaluable or measurable disease by RECIST criteria for solid tumors.
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.

Exclusion Criteria

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 clinically significant unexplained bleeding within 28 days prior to entering the study.
Patients with hemoptysis within 28 days prior to entering the study.
...
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 clinically significant unexplained bleeding within 28 days prior to entering the study.
Patients with hemoptysis within 28 days prior to entering the study.
Patients with untreated or progressing brain metastases.
Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
Pregnant or lactating women.
Major surgery within 28 days prior to the first dose of study medication.
Patients who had radiation to greater than 25% marrow in the past 5 years.
KRAS mutated colorectal cancer.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.

Summary

Conditions
Advanced Cancers
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 125 years
Gender
Both males and females

Description

Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a dose level of the study drugs based on when you join the study. Up to 5 dose level combinations of regorafenib and cetuximab will be tested. Up to 3 participants will be enrolled at each dose level. T...

Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a dose level of the study drugs based on when you join the study. Up to 5 dose level combinations of regorafenib and cetuximab will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level combination. Each new group will receive a higher dose of either regorafenib or cetuximab than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose combination of regorafenib and cetuximab are found. Once the highest tolerable dose combination is found, up to 10 more participants may be enrolled. This group (called the Dose Expansion group) is enrolled to help researchers study the safety and effectiveness of this dose level combination. Study Drug Administration: Each study cycle is 28 days. You will take regorafenib by mouth on Days 1-5, 8-12, and 15-19 of each cycle. You will swallow the whole capsules with 1 cup of water (about 8 ounces) 1 time a day. Do not break, chew, or open your capsules. The doctor will discuss this with you. You will receive cetuximab by vein over about 1-2 hours on Days 1, 8, 15, and 22 of each cycle. Study Visits: At each cycle, you will be asked to complete a questionnaire so the study team will better understand any symptoms you may be having that are related to use of the study drug. On Day 1 of Cycle 1, blood (about 4 teaspoons) and urine will be collected for routine tests and pharmacodynamic (PD) tests. PD testing measures how the level of study drug in your body may affect the disease. Between Days 8 and 14, Days 15 and 21, and Days 22 and 28 of Cycle 1: °Blood (about 4 teaspoons) will be drawn for routine tests. On Day 1 of Cycles 2 and beyond: You will have a physical exam. Urine will be collected for routine tests. Once a week, blood (about 4 teaspoons) will be drawn for routine tests. Every other cycle (every 8 weeks): °You will have an x-ray and a CT scan to check the status of the disease. Length of Study: You may continue receiving regorafenib and cetuximab for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. You will be off study after the end-of-study visit. End of Study Visit: About 30 days after your last dose of study drugs: You will have a physical exam. Blood (about 4 teaspoons) and urine will be collected for routine and PD tests tests. You will have an x-ray and a CT scan to check the status of the disease. Follow-up: You will be asked about any health problems you may have and if you have had any side effects. If your study doctor thinks it is needed, you may have follow-up for a longer period of time. This is an investigational study. Regorafenib is FDA approved for the treatment of metastatic colorectal cancer. Cetuximab is FDA approved for the treatment of K-Ras wild type colorectal cancer as well as head and neck cancer. The combination of regorafenib and cetuximab is currently being used in advanced solid tumor patients for research purposes only. Up to 83 patients will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria

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.
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 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 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.
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 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.
Ability to understand and the willingness to sign a written informed consent document.
ECOG performance status </= 2 (Karnofsky >/= 60%).
Patient must be >= 12 years of age and > 40kgs.
Patients must have evaluable or measurable disease by RECIST criteria for solid tumors.
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.

Exclusion Criteria

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 clinically significant unexplained bleeding within 28 days prior to entering the study.
Patients with hemoptysis within 28 days prior to entering the study.
...
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 clinically significant unexplained bleeding within 28 days prior to entering the study.
Patients with hemoptysis within 28 days prior to entering the study.
Patients with untreated or progressing brain metastases.
Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
Pregnant or lactating women.
Major surgery within 28 days prior to the first dose of study medication.
Patients who had radiation to greater than 25% marrow in the past 5 years.
KRAS mutated colorectal cancer.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.

Tracking Information

NCT #
NCT02095054
Collaborators
Not Provided
Investigators
  • Principal Investigator: Vivek Subbiah, MD M.D. Anderson Cancer Center
  • Vivek Subbiah, MD M.D. Anderson Cancer Center
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