MDACC Study Summary 2009-0432

Study Summary
No. 2009-0432:.......Melanoma......Agop Y. Bedikian......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2009-0432

Study Title:	Phase I Study of Weekly LOC-paclitaxel Injection

Physician

New Patient Referral



Name:	Agop Y. Bedikian	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-792-2921 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	Luitpold Pharmaceutical, Inc.

Phase of Study:	Phase I	Return Visit:	Every 6 weeks.

Treatment Agents:	LOC-paclitaxel	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find the highest tolerable dose of LOC-paclitaxel when given to patients with metastatic melanoma. The safety of this drug and if it can control the disease is also being studied.

Study Objectives / Outcomes

Part I

1. To determine the recommended dose of LOC-paclitaxel as a single agent, given weekly, 5/6 weeks.
2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of weekly LOC-paclitaxel.
3. To measure the plasma pharmacokinetics of LOC-paclitaxel and paclitaxel derived from LOC-paclitaxel in patients receiving escalating doses of weekly LOC-paclitaxel.
4. To document any observed antitumor activity.

Part II

1. To confirm the Phase II dose of weekly LOC-paclitaxel.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	12/23/2009

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) Patient must have histologically or cytologically confirmed malignant solid tumors.

2) Patients must have failed conventional therapy for their cancer or have a malignancy for which a conventional therapy does not exist.

3) Patients must have recovered from all acute toxicities from prior therapies, excluding alopecia.

4) Patients must have an ECOG performance status of 0, 1, or 2.

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

6) Patients must have adequate liver and renal function as defined by serum creatinine, total bilirubin, AST, and ALT levels within normal limits.

7) Patients must have adequate bone marrow function as defined by a hemoglobin >/= 10g/dL, an absolute neutrophil count of >/= 1,500/mm^3, and platelet count of >/= 100,000/mm^3.

8) 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.

9) Patients must have a life expectancy of at least three months.

Exclusion Criteria:

1) Patients who have therapies available that have demonstrated clinical benefit.

2) Patients with known or clinical evidence of CNS metastases.

3) Women who are pregnant or nursing and patients (men or women) 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. Women may not breastfeed while on this study.

4) Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).

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

6) 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.

7) Patients with a known hypersensitivity to CREMOPHOR� and/or paclitaxel.

8) Patients must not have had recent major surgery within the past 14 days or large field radiation therapy or chemotherapy in the last 28 days. If the previous chemotherapy included nitrosoureas or mitomycin C, this period will be 6 weeks.

9) Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study. Previous palliative radiotherapy is allowed for metastatic disease in a region that is not part of the disease being measured.

10) Patients must not have had radiation to >/= 25% of the bone marrow.

11) Patients with Gilbert's Syndrome.

12) Patients with known HIV disease or infection.

13) Simultaneous participation in another clinical trial of an investigational agent or device.

14) Patients receiving ketoconazole, erythromycin, verapamil, diazepam, quinidine, diltiazem, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine, fluoxetine or gemfibrozil. Patients taking any of these drugs may qualify for treatment on this investigational study if they have been off the drug at least for 7 days.

Links

Registration Number: NCT01039844
Study Information on Clinical Trials Registry (clinicaltrials.gov)