Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab
NCT ID: NCT01213238
Last Updated: 2019-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
116 participants
INTERVENTIONAL
2010-09-30
2018-09-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis
NCT00491855
Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients
NCT00583622
Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
NCT01081262
Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
NCT00079430
Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer
NCT01220154
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Oxaliplatin is designed to keep new cancer cells from growing.
Capecitabine is designed to interfere with the growth of cancer cells.
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells. Bevacizumab is no longer FDA approved to treat breast cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study "arm" based on the results of your screening tests. All patients will receive oxaliplatin and capecitabine. If your doctor thinks it is in your best interest, you will also receive bevacizumab.
* If you are in Arm 1, you will receive oxaliplatin, capecitabine, and bevacizumab.
* If you are in Arm 2, you will receive oxaliplatin and capecitabine.
Arm 1:
You will be assigned to a dose level of capecitabine based on when you joined this study. Up to 4 dose levels of capecitabine will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of capecitabine is found.
All participants will receive the same dose levels of oxaliplatin and bevacizumab.
Arm 2:
You will be assigned to a dose level of capecitabine based on when you joined this study. Up to 4 dose levels of capecitabine will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of capecitabine is found.
All participants will receive the same dose levels of oxaliplatin.
Additionally, after the highest tolerable dose is found for each arm, if a certain tumor type is found to have responded well to the study drug combination, 14 participants with that tumor type will receive the study drugs at that dose level.
In each arm, after the highest tolerable dose of the study drug combination is found, up to 20 extra participants with any tumor type will receive that dose level.
Additionally, after the highest tolerable dose is found for each arm, if a certain tumor type is found to have responded well to the study drug combination, 14 participants with that tumor type will receive the study drugs at that dose level.
Catheter Placement for Study Drug Administration:
You will be hospitalized to receive the study drug combination. On the day of your admission to the hospital, you will have a catheter (a sterile flexible tube that will be placed in the hepatic artery \[a blood vessel in the liver\] while you are under local anesthesia) through which you will receive the study drugs. The catheter will be placed and removed during each cycle. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
You must lay in bed for the entire time that the catheter is in place. The catheter will either be removed right after your chemotherapy or it may remain in overnight.
Study Drug Administration:
Arm 1:
After completion of oxaliplatin and bevacizumab, you will receive a total of 28 doses of capecitabine, 1 dose twice daily. You will then receive bevacizumab by vein over 1½ hours. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of the doses will be given over 30-60 minutes.
On Days 1-14 of each cycle, you will take capecitabine by mouth 2 times each day. You should take it with a cup (8 ounces) of non-carbonated water within 30 minutes after a meal.
Arm 2:
On Day 1 of each 21-day cycle, you will receive oxaliplatin through the catheter over 2 hours.
After completion of oxaliplatin and bevacizumab, you will receive a total of 28 doses of capecitabine, 1 dose twice daily. You should take it with a cup (8 ounces) of non-carbonated water within 30 minutes after a meal.
Study Visits:
At each study visit, you will be asked about any other drugs you may be taking and about any side effects you may be having.
On Day 1 of each cycle:
* You will have a physical exam, including measurement of your weight and vital signs.
* Blood (about 4 teaspoons) will be drawn for routine tests.
* Blood (about 1 teaspoon) will be drawn to test your blood's ability to clot.
* If you are able to become pregnant, you will have a urine pregnancy test.
At the end of every even cycle (Cycles 2, 4, 6, and so on):
* Blood (about 1 tablespoon) will be drawn to test for tumor markers.
* You will have scans to check the status of the disease. This may include a chest x-ray, CT scan, MRI scan, a PET scan, and/or a PET/CT scan. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed.
Length of Study:
You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug combination if the disease gets worse or intolerable side effects occur.
If the disease is only in your liver and you have responded to treatment, you may be eligible to receive surgery. If eligible, you will receive surgery 6 weeks after taking your last dose of study drugs if you are in Arm 1 or 4 weeks after taking your last dose of study drugs if you are in Arm 2. The study doctor will discuss this with you in more detail and you will sign a separate consent form if you have surgery.
Your participation on the study will be over once you have completed the follow-up visit.
Follow-Up Visit:
About 6 weeks after your last dose of study drugs, the following tests and procedures will be performed:
* You will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests.
* You will have a CT scan, MRI scan, PET scan, or PET/CT scan to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans may also be performed.
This is an investigational study. Oxaliplatin is FDA approved and commercially available for the treatment of colorectal cancer. Bevacizumab is FDA approved and commercially available for the treatment of colorectal and lung cancers. Capecitabine is FDA approved and commercially available for the treatment of colorectal and breast cancers.
Giving the study drugs together for advanced cancer is investigational.
Up to 116 participants will take part in this study. All will be enrolled at MD Anderson.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oxaliplatin + Capecitabine + Bevacizumab
Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle. Bevacizumab 10 mg/kg by vein on day 1 of a 21 day cycle.
Oxaliplatin
140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.
Capecitabine
Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.
Bevacizumab
10 mg/kg by vein on day 1 of a 21 day cycle.
Oxaliplatin + Capecitabine
Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 -14 of a 21 day cycle.
Oxaliplatin
140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.
Capecitabine
Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oxaliplatin
140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.
Capecitabine
Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.
Bevacizumab
10 mg/kg by vein on day 1 of a 21 day cycle.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities).
3. Adequate renal function (creatinine clearance \>50 mL/min).
4. Adequate liver function: total bilirubin \</= 4 mg/dL, alanine transaminase (ALT) \</= 5 times upper normal reference value. Patients with total bilirubin between 3.0 and 4.0 mg/dL must have blood ammonia level checked at baseline. Blood ammonia level must be within normal limits for enrollment.
5. Adequate bone marrow function (absolute neutrophil count (ANC) \>/= 1000 cells/uL; platelets (PLT) \>/= 70,000 cells/uL).
6. At least 3 weeks from prior cytotoxic chemotherapy or radiation therapy. If targeted or biologic therapy, there should be at least 5 half lives or 3 weeks, whichever is shorter, from day 1 of treatment.
7. All females in childbearing age MUST have a negative urine human chorionic gonadotropin (HCG) test before the first dose, unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). Patients should not become pregnant or breast-feed while on this study. Sexually active patients should use effective birth control.
8. Ability and willingness to sign informed consent form.
9. Must be \>/= 18 years of age.
10. Patients with unresectable liver-only (isolated liver) metastases are eligible; those who show adequate response may be considered for liver resection and/or radiofrequency ablation (RFA) of remaining disease.
Exclusion Criteria
2. Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
3. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
4. Patients already in uncompensated liver failure (i.e., Child Pugh Liver Classification C).
5. History of hypersensitivity to any component of the formulation.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Apostolia M. Tsimberidou, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
University of Texas MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2012-01901
Identifier Type: REGISTRY
Identifier Source: secondary_id
2010-0413
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.