HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver
This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00980239
First received: September 17, 2009
Last updated: March 5, 2013
Last verified: March 2013
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Purpose
The goal of this clinical research study is to learn the highest tolerable dose of irinotecan that can be given directly into the liver, in combination with other drugs given by vein.
The other drug combinations given by vein include bevacizumab alone, bevacizumab plus oxaliplatin, and bevacizumab plus cetuximab.
This will be tested in patients with advanced solid tumors that have spread to the liver. The safety of these drug combinations will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer Advanced Cancer |
Drug: Irinotecan Drug: Bevacizumab Drug: Oxaliplatin Drug: Cetuximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-arm Phase I Trial of Hepatic Arterial Infusion of Irinotecan With 1) Systemic Bevacizumab 2) Systemic Bevacizumab and Oxaliplatin 3) Systemic Bevacizumab and Cetuximab in Patients With Advanced Cancers Metastatic to the Liver |
Resource links provided by NLM:
Drug Information available for:
Oxaliplatin
Irinotecan
Irinotecan hydrochloride
Cetuximab
Bevacizumab
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Doses (MTDs) [ Time Frame: Evaulated with each 28 day cycle ] [ Designated as safety issue: Yes ]
- Dose-limiting toxicities (DLTs) [ Time Frame: Evaulated with each 28 day cycle ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 140 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Group 1 = Irinotecan + Bevacizumab
|
Drug: Irinotecan
Starting dose of 35 mg/m^2 given through the catheter into your liver artery (hepatic artery infusion - HAI), continuously for 72 hours (Days 1 through 2 of each cycle).
Other Names:
Drug: Bevacizumab
10 mg/Kg by vein on Days 1 and 15 of every 28 day cycle, over 90 minutes first cycle and over 30-60 minutes subsequent cycles.
Other Names:
|
|
Experimental: Group 2
Group 2 = Irinotecan, Bevacizumab + Oxaliplatin
|
Drug: Irinotecan
Starting dose of 35 mg/m^2 given through the catheter into your liver artery (hepatic artery infusion - HAI), continuously for 72 hours (Days 1 through 2 of each cycle).
Other Names:
Drug: Bevacizumab
10 mg/Kg by vein on Days 1 and 15 of every 28 day cycle, over 90 minutes first cycle and over 30-60 minutes subsequent cycles.
Other Names:
Drug: Oxaliplatin
Starting dose 60 mg/m^2 by vein over 2 hours on Days 1 and 15 of every cycle.
Other Name: Eloxatin
|
|
Experimental: Group 3
Group 3 = Irinotecan, Bevacizumab + Cetuximab
|
Drug: Irinotecan
Starting dose of 35 mg/m^2 given through the catheter into your liver artery (hepatic artery infusion - HAI), continuously for 72 hours (Days 1 through 2 of each cycle).
Other Names:
Drug: Bevacizumab
10 mg/Kg by vein on Days 1 and 15 of every 28 day cycle, over 90 minutes first cycle and over 30-60 minutes subsequent cycles.
Other Names:
Drug: Cetuximab
500 mg/m^2 by vein on Days 1 and 15 of every cycle. The first time given over 2 hours, all other cycles over 1 hour.
Other Names:
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histologically confirmed metastatic advanced cancers with liver involvement.
- Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months, unless the drugs included in the regimen are part of their standard treatment.
- Irinotecan will be dosed regardless of creatinine clearance. For oxaliplatin, serum creatinine </= 2.5 times the upper limit of normal or creatinine clearance >/= 40 is required.
- Hepatic function: T. Bilirubin </= 3 mg/dl, ALT </= 5 X upper limits of normal (ULN).
- Adequate bone marrow function (ANC >/=1000 cells/uL; platelet (PLT) >/= 100,000 cells/uL).
- Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- All females in childbearing age MUST have a negative serum or urine pregnancy test 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.
- Eastern Cooperative Oncology Group (ECOG) Performance status </= 2.
Exclusion Criteria:
- Pregnant females.
- Patients with colorectal cancer and K-RAS mutation will be excluded from the cetuximab arm.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
- Invasive procedures defined as follows: a. Major surgical procedure within 28 days prior to Day 1 therapy. b. Anticipation of need for major surgical procedures during the course of the study.
- Patients receiving any other investigational agents.
- Patients with bleeding diathesis (clinical bleeding, prothrombin time >/= 1.5 X upper institutional normal value, international normalized ratio (INR) >/=1.5, activated partial thromboplastin time (aPTT) >/= 1.5 X upper institutional normal value, NOT due to anticoagulation therapy), active gastric or duodenal ulcer.
- Patients with history of bleeding central nervous system (CNS) metastasis will be excluded from the trial.
- Hypersensitivity to any of the drugs in a particular treatment arm.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow up requirements.
- History of heparin-induced thrombocytopenia.
- Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980239
Contacts
| Contact: Apostolia M. Tsimberidou, MD, PhD | 713-792-4259 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Apostolia M. Tsimberidou, MD, PhD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Apostolia M. Tsimberidou, MD, PhD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00980239 History of Changes |
| Other Study ID Numbers: | 2009-0410 |
| Study First Received: | September 17, 2009 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Solid Tumors Liver hepatic arterial infusion HAI Bevacizumab Avastin |
Cetuximab Erbitux Irinotecan Camptosar Oxaliplatin Eloxatin |
Additional relevant MeSH terms:
|
Liver Neoplasms Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Antibodies, Monoclonal Oxaliplatin Irinotecan Bevacizumab Cetuximab Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013