MDACC Study Summary 2007-0857

Study Summary
No. 2007-0857:.......Advanced Cancers; Liver; Solid Tumors......Siqing Fu......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2007-0857

Study Title:	Phase I trial of hepatic arterial infusion of Abraxane with a pharmacokinetic study in advanced solid cancer patients with predominant hepatic metastases

Physician

New Patient Referral



Name:	Siqing Fu	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:	713-794-1226 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers Liver Solid Tumors	Supported By:	National Comprehensive Cancer Network

Phase of Study:	Phase I	Return Visit:	pre-study, days 1 and 2 of cycle 1 and 2, weekly during therapy, off study

Treatment Agents:	Abraxane	Home Care:	none

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	none


Description/ Intervention:	The goal of this clinical research study is find the highest tolerated dose of Abraxane (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer that has spread to the liver.

Study Objectives / Outcomes

Primary Objectives
1. To determine the maximum tolerated doses of hepatic arterial infusion (HAI) of Abraxane in advanced solid cancer patients with predominant hepatic metastases.

2. To compare pharmacokinetic analyses of HAI Abraxane and intravenous Abraxane, especially the time to peak that might be a more sensitive indicator of the effect of first-pass hepatic extraction on drug bioavailability.

Secondary Objectives
1. To assess by RECIST clinical responses signals in a broad array of solid tumors.

2. To evaluate whether dynamic contrast enhanced MRI to determine the degree of vascular permeability and PET scan to delineate tumor viability and glucose uptake are able to predict major clinical outcomes.

Study Status Information



Study Activation / Registration Date:	06/25/2008

IRB Review and Approval Date:	06/25/2008

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) Pathologically confirmed diagnosis of advanced malignancy and liver involvement as predominant site of metastasis.

2) An ECOG performance status of 0-2

3) Adequate end-organ function as follows: ANC > or = 1500/mm3, Platelets > or = 100,000/mm3, Creatinine < or = 2.0 mg/dL or the calculated GFR > or = 40 mL/min if Creatinine > 2.0 mg/dL, ALT < or = 5 times upper limits of normal, Hb > 9.0 and Bilirubin < or = 2.0 mg/dL.

4) Refractory to standard cancer therapy or who have no conventional therapy that produces a complete response rate of at least 10% or an increase in survival of at least 3 months.

5) Ability to fully comprehend and willingness to sign the IRB-approved informed consent

6) Full recovery from any previous therapy and ability to receive cytotoxic agents.

7) Patient is 18 years of age or older

Exclusion Criteria:

1) Clinically significant ascites.

2) Pregnant or breastfeeding females. Women of childbearing potential should be advised to avoid becoming pregnant and men to not father a child while receiving treatment. Women of childbearing potential must have a negative pregnancy test.

3) Hypersensitivity to Abraxane

4) Untreatable bleeding diathesis

5) Evidence of portal vein thrombosis and clinically significant peripheral vascular disease

6) Neuropathy of grade 2 or higher

7) A known history of CNS metastasis unless the patients are neurologically stable after treatment with surgery and/or radiation therapy

8) If the patient progressed on abraxane previously they will not be eligible for the dose escalation portion or the PK studies only. These pateints can be included in the dose expansion portion of the trial.

Links

Registration Number: NCT00732836
Study Information on Clinical Trials Registry (clinicaltrials.gov)