MDACC Study Summary 2009-0023

Study Summary
No. 2009-0023:.......Advanced Cancers......Apostolia M. Tsimberidou......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2009-0023

Study Title:	A phase I study of hepatic arterial infusion of oxaliplatin and/or fluorouracil in combination with systemic fluorouracil, leucovorin, bevacizumab, and/or cetuximab by KRAS mutational status and liver function for patients with advanced cancers metastatic to the liver

Physician

New Patient Referral



Name:	Apostolia M. Tsimberidou	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Investigational Cancer Therapeutics	Referring 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	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Baseline, Days 3-5 of each 21 day cycle.

Treatment Agents:	5-Fluorouracil Bevacizumab Cetuximab Leucovorin Oxaliplatin	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Days 1 and 2 of each 21 day cycle.


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

1. To determine the toxicity and tolerability of intra-arterial hepatic oxaliplatin every three weeks administered in combination with systemic intravenous fluorouracil, leucovorin, and bevacizumab +/- cetuximab in patients with advanced cancers metastatic to the liver.

2. To assess anti-tumor efficacy of this combination regimen.

Study Status Information



Study Activation / Registration Date:	07/14/2009

IRB Review and Approval Date:	07/14/2009

Study Type:	Phase I

Recruitment Status:	Open

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 must have histologically confirmed cancer with metastatic liver metastases.

2) Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months, unless the drugs in the protocol regimen are part of the standard of care.

3) Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (Capable of all self care but unable to carry out any work activities). Pediatric: performance status Karnovsky (>10) or Lansky (<10).

4) Adequate renal function (Serum Creatinine </= 2.0 mg/dL). Pediatric: serum creatinine </= 1.5 mg/dL or 2x upper limit of normal, for age.

5) Patients will be stratified by liver function tests: Normal liver function: Total Bilirubin </= 3 mg/dL, Alanine aminotransferase (ALT) </= 5 times upper normal reference value. Abnormal liver function: Total bilirubin >3 mg/dL and/or elevated ALT > 5 x upper limit of normal (ULN). If bilirubin is >/= 5 mg/dL, fluorouracil (5FU) dose will be omitted. Both of the above groups will be eligible.

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

7) At least three weeks from previous cytotoxic chemotherapy before day 1 of hepatic arterial infusion (HAI) infusion. After targeted or biologic therapy, there should be 5 half-lives or three weeks, whichever is shorter.

8) All females in childbearing age MUST have a negative urine human chorionic gonadotropin (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 sign informed consent form. Pediatric: age 7-18 would sign assent, (<7 would not assent), parent or guardian would sign consent.

10) Patients with colorectal cancer must agree to K-RAS mutational status screening, if not available. If tissue is not available, patients can enter on trial, but not on the cetuximab arms.

Exclusion Criteria:

1) Pregnant females.

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

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

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

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

6) 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.

7) Patients already in uncompensated liver failure (i.e. Child Pugh Liver Classification C).

Links

Registration Number: NCT00941499
Study Information on Clinical Trials Registry (clinicaltrials.gov)