HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver

Completed · Phase 1

Conditions studied: Liver Cancer, Advanced Cancer

In brief

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.

Key facts

Study ID: NCT00980239
Run by: M.D. Anderson Cancer Center
People needed: 115
Starts: 2009-09-01
Expected to finish: 2015-08-01
Last updated by the study team: 2015-11-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 </= 5X upper limit of normal (ULN).
Adequate bone marrow function (ANC >/=1000 cells/uL; 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.

You may not qualify if…

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 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).

Where it is running

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

Full record on ClinicalTrials.gov

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