Return to List

Study Summary
No. 2006-0160:.......Advanced Cancers; Phase I Studies; Solid Tumors......Apostolia M. Tsimberidou......Phase I Program
.
Study Summary Title
Study Summary
Number:
2006-0160
Study Title:A Phase I Study of Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic Fluorouracil, Leucovorin and Avastin for Patients with Advanced Solid Tumors Metastatic to the Liver.
.
Physician New Patient Referral
Name:Apostolia M. TsimberidouPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Phase I ProgramReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-4259
Contact us about clinical trials
.
General Information
Disease Group:Advanced Cancers
Phase I Studies
Solid Tumors
Supported By:N/A
Phase of Study:Phase IReturn
Visit:
Patients will return every two to three weeks for treatment.
Treatment
Agents:
5-Fluorouracil
Avastin
Leucovorin
Oxaliplatin
Home Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
3-7 Days
Description/
Intervention:
The goal of this clinical research study is to find the highest tolerable dose
of oxaliplatin used in combination with 5-fluorouracil, leucovorin, and
AvastinŽ (bevacizumab) for patients with advanced cancer that has spread to the
liver. The safety and effectiveness of this study drug combination will also be
studied.
.
Study Objectives / Outcomes
PRIMARY
  • To determine the toxicity and tolerability of intra-arterial hepatic oxaliplatin every three weeks administered in combination with systemic intravenous Fluorouracil, Leucovorin and bevacizumab to patients with advanced solid tumors metastatic to the liver.


SECONDARY
  • To document in a descriptive fashion the antitumor efficacy of this combination regimen.
  • To evaluate the feasibility and accuracy of an alternate radiographic assessment tool and compare with available tumor markers and RECIST guidelines.
  • To estimate in a descriptive fashion the development of extrahepatic tumor recurrences.
.
Study Status Information
Study Activation / Registration Date:06/14/2006
IRB Review and Approval Date:05/03/2006
Study Type:Phase I
Recruitment Status:Terminated
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients with histologically confirmed metastatic advanced solid tumors involving the liver.

2) Pediatric patients eligible at the discretion of the primary investigator.

3) Performance status ECOG 0-2 (Capable of all self care but unable to to carry out any work activities).

4) Adequate renal function (Serum Creatinine </= 2.0 mg/dL) or a calculated creatinine clearance greater than 60 mL/min.

5) Hepatic function as follows: In treatment arm 1: Total Bilirubin </= 3 mg/dL, AST </= 5 times upper normal reference value, or ALT </= 5 times upper normal reference value). In treatment arm 2: Total bilirubin >3 mg/dL. If bilirubin >/= 5 mg/dL, fluorouracil (5FU) dose will be omitted.

6) Adequate bone marrow function (ANC >/=1500 cells/uL; PLT >/= 100,000 cells/uL).

7) At least three weeks from previous immunotherapy, chemotherapy or radiotherapy before day of HAI infusion and recovery from any associated toxicities to less or equal to Grade 1.

8) All females in childbearing age MUST have a negative serum HCG 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.

9) Ability to fully read, comprehend, and sign informed consent forms.

Exclusion Criteria:1) Pregnant females.

2) Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.

3) Grade 2 Peripheral Neuropathy (CTC V3.0: Sensory alteration interfering with function but not interfering with ADL)

4) Serious or non-healing wound, ulcer or bone fracture.

5) History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.

6) Invasive procedures defined as follows; Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 therapy, Anticipation of need for major surgical procedures during the course of the study, Core biopsy within 7 days prior to D1 of therapy.

7) Patients receiving any other investigational agents.

8) Patients with bleeding diathesis (clinical bleeding, prothrombin time =/> 1.5 X upper institutional normal value, INR =/> 1.5, activated partial thromboplastin time aPTT =/> 1.5 X upper institutional normal value), active gastric or duodenal ulcer.

9) Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, Diastolic Blood Pressure > 90 mmHg).

10) Urine protein should be screened by dipstick or urine analysis. For proteinuria > 1+ or urine protein:creatinine ratio > 1.0, a 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment.

11) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.

12) Patients with clinically significant cardiovascular disease: History of CVA within 6 months, myocardial infarction or unstable angina within 6 months, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris, clinically significant peripheral vascular disease

13) Patients with history of bleeding CNS metastasis will be excluded from the trial.

.
Links
Registration Number: NCT00507585
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center