Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall goal of this study is to determine the safety and efficacy of combination treatment of low-dose fractionated radiation therapy with gemcitabine-cisplatin chemotherapy for locally advanced mass forming intra-hepatic cholangiocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allina Health System
• Collaborator: Abbott Northwestern Hospital
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Histologic diagnosis of mass-forming IHC. OR

• Histologic diagnosis of adenocarcinoma of the liver in setting of negative colonoscopy, upper endoscopy, mammography (females), or cross-sectional imaging for primary disease.

• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with spiral CT scan, MRI. See Section 8 for the evaluation of measurable disease.

• Locally advanced disease (portal lymph node disease, multifocal intrahepatic lesions, or major vascular invasion) AND no evidence of omental, peritoneal, or pelvic metastases.

• Other sites of metastatic disease (e.g. lung, distant lymph nodes, bone) are allowed.

• No prior chemotherapy, radiotherapy, or surgical therapy.

• ECOG performance status ≤ 1 (Karnofsky ≥70%). See Appendix A.

• Life expectancy of greater than six months.

• Patients must have normal organ and marrow function as defined below:

• leukocytes≥3,000/mcL

• absolute neutrophil count≥1,500/mcL

• platelets ≥100,000/mcL

• hemoglobin≥9.0 g/dL

• total bilirubin≤2.0 mg/dL

• AST(SGOT)/ALT(SGPT)≤3 × institutional upper limit of normal

• creatinine within normal institutional limits OR

• creatinine clearance≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

• int'l normalized ratio<1.8

• systolic blood pressure≤160 mmHg

• diastolic blood pressure ≥90 mmHg

• For women of child-bearing potential, negative serum pregnancy test within 14 days prior to registration.

• Women of childbearing age and male participants.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Prior chemotherapy, surgical therapy, or radiotherapy for IHC.

• Patients who are receiving any other investigational agents or have been treated with any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.

• Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or cisplatin.

• Prior invasive malignancy (except for non-melanomatous skin cancer, low grade prostate cancer, and in situ cervical cancer) unless disease free for ≥ two years.

• Periductal infiltrating, intraductal, or poorly differentiated neuroendocrine (e.g. high grade, small, or large cell) tumor histology.

• Prior abdominal radiotherapy.

• Cirrhosis, primary sclerosing cholangitis, hepatitis viral infection (documented by positive serology and antigen serologic testing), or other background liver diseases.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; unstable angina and/or congestive heart failure within the last 6 months; transmural myocardial infarction within the last 6 months; New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration; history of stroke, cerebral vascular accident or transient ischemic attack within 6 months; serious and inadequately controlled cardiac arrhythmia; significant vascular disease (e.g.;, high risk aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease; evidence of bleeding diathesis or coagulopathy; serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess, major surgical procedure or significant traumatic injury within 28 days prior to registration; bacterial or fungal infection requiring intravenous antibiotics at the time of registration; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity; any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy; cognitive impairment that precludes a patient from acting as his or her own agent to provide informed consent.

• Pregnant or breast feeding women.

• Men and women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception.

• Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol are significantly immunosuppressive.