MDACC Study Summary 2006-0566 (Archived)

Study Summary
No. 2006-0566:.......Biliary Tract; Gallbladder; Liver......Ahmed Kaseb......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2006-0566

Study Title:	Phase II Open-Label Study of Weekly TaxoprexinŽ (DHA-paclitaxel) Injection as Second Line Therapy for Patients with Advanced Primary Cancers of the Liver, including Hepatocellular Carcinoma (HCC) and Carcinoma of the Gallbladder or Biliary Tract (BTC) (P01-05-23)

Physician

New Patient Referral



Name:	Ahmed Kaseb	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gastrointestinal Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2828 Contact us about clinical trials

General Information



Disease Group:	Biliary Tract Gallbladder Liver	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every week.

Treatment Agents:	Taxoprexin	Home Care:	NA

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	No hospitalization is needed.


Description/ Intervention:	The goal of this clinical research study is to learn if TaxoprexinŽ (DHA-paclitaxel) can help to control liver, gallbladder, or biliary tract cancer that has spread or is unable to be surgically removed. The safety of DHA-paclitaxel will also be studied.

Study Objectives / Outcomes

Primary Objectives:

To evaluate the objective response rate and duration of response of patients with unresectable hepatocellular carcinoma (HCC) or biliary tract cancer (BTC) treated with weekly Taxoprexin

^Ž

To evaluate the safety profile of weekly Taxoprexin

^Ž

in this patient population.

Secondary Objectives:

To evaluate the overall survival of patients with HCC or BTC when treated with weekly Taxoprexin

^Ž

To evaluate time to progression (TTP) and time to treatment failure (TTF) in patients with HCC or BTC when treated with weekly Taxoprexin

^Ž

To explore the trough and peak levels of Taxoprexin

^Ž

and paclitaxel in these patient populations.

Study Status Information



Study Activation / Registration Date:	01/12/2007

IRB Review and Approval Date:	08/02/2006

Study Type:	Phase Ii Or Phase I/Ii

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 must have histologic or cytologic confirmation of primary cancer of the liver, including HCC or adenocarcinoma of the gallbladder or bile ducts and advanced (unresectable and/or metastatic) disease.

2) Patients must have at least one measurable lesion by RECIST criteria. If it is a visceral or nodal or soft tissue lesion, it must be >/= 20 mm with conventional techniques or >/= 10 mm with spiral CT and/or MRI scan. Bone lesions are not considered measurable.

3) Patients may have received up to two prior systemic non-cytotoxic regimens for their disease. Prior treatment with immunologic and/or biologic agents (e.g., interferon, monoclonal antibodies, tyrosine kinase inhibitors) is allowed provided there is documentation of disease progression. Prior treatment with hepatic arterial chemotherapy infusion/perfusion, chemo-embolization of liver metastasis, or radiation therapy is allowed as long as there is disease outside the previously treated region or clear progression of liver metastases.

4) At least 6 weeks (42 days) since any prior immunologic or biologic therapy.

5) At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow or prior adjuvant chemotherapy.

6) Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.

7) Patients must have ECOG performance status of 0 - 2.

8) Patients must be >/= 18 years of age.

9) Patients must have adequate liver and renal function as defined by total bilirubin no greater than 1.5 times the institution's upper normal limit, transaminase levels (i.e., ALT and AST) no higher than 5.0 times the institution's upper normal limits and serum creatinine no greater than the institution's upper normal limit or estimated Creatinine Clearance >60ml/min*. * Formula: Male : Clcr (ml/min) = (140 - age ) x (tbw)(kg) divided by 72 x serum creatinine(mg/dl); Female : Clcr (ml/min) = 0.85 x ( 140 - age ) x (tbw)(kg) divided by 72 x serum creatinine(mg/dl)

10) Patients must have adequate bone marrow function as defined by an absolute neutrophil count of >/= 1,500/mm^3, and platelet count of >/= 75, 000/mm^3 and hemoglobin > 9 gm/d.

11) Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.

Exclusion Criteria:

1) Patients who have received prior therapy with any taxane.

2) Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.

3) Patients with symptomatic brain metastasis(es) or patients with uncontrolled brain metastasis(es) who (by definition): a. require oral steroids for cerebral edema or; b. have new lesion(s) on CT/MRI or; c. have progression on CT/MRI.

4) Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential. Patients may not breastfeed while on this study.

5) Patients with current active infections (this includes simple infections such as a UTI) currently receiving anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).

6) Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).

7) Patients with unstable or serious concurrent medical conditions are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.

8) Patients with a known hypersensitivity to Cremophor.

9) Patients with one or more of the following as the only manifestations of disease are ineligible: bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, carcinomatous lymphangitis, CNS metastases, lesions in a previously irradiated area that have not shown definite progression, or disease only inferred from laboratory tests or markers.

10) Patients with a history of Gilbert's Syndrome.

11) Patients must not receive any concurrent chemotherapy, radiotherapy, non-FDA approved nutritional supplements or herbal preparations or immunotherapy while on study.

12) Known HIV disease or infection.

13) Patients receiving ketoconazol, erythromycin, verapamil, diazepam, quinidine or diltiazem.

14) Patients must not have had any surgical procedure requiring hospitalization and administration of general anesthesia within the past 28 days.

15) Patients must not have received prior systemic chemotherapy for advanced disease. Prior adjuvant systemic chemotherapy (non-taxane containing) is allowed.

Links

Registration Number: NCT00422877
Study Information on Clinical Trials Registry (clinicaltrials.gov)