Phase II Open-Label Study of Weekly Taxoprexin® (DHA-paclitaxel) Injection as Treatment of Patients with Metastatic Uveal (Choroidal) Malignant Melanoma
Agop Y. Bedikian
The goal of this clinical research study is to learn if a new drug, Taxoprexin® (DHA-paclitaxel) can help to control metastatic choroidal melanoma. The safety of DHA-paclitaxel will also be studied.
Disease Group: Melanoma
Treatment Agent: Taxoprexin
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: N/A
Return Visit: On days 1, 8, 15, 22 and 29, every 42 days (six weeks).
Home Care: N/A
Primary Objectives: 1. To evaluate objective response rate of patients with metastatic choroidal melanoma and duration of response to weekly Taxoprexin®. 2. To evaluate the safety profile of weekly Taxoprexin® in this patient population. Secondary Objectives: 1. To evaluate the overall survival of patients with metastatic choroidal melanoma when treated with weekly Taxoprexin®. 2. To evaluate the time to progression (TTP) and time to treatment failure (TTF) in patients with malignant melanoma when treated with weekly Taxoprexin®.
IRB Review and Approval Date: JUL 20,2005
Recruitment Status: Not Accepting
Projected Accrual: N/A
1) Patients must have histologic or cytologic confirmation of malignant
uveal (choroidal) melanoma, and documented metastatic disease.
2) Patients must have at least one unidimensionally measurable lesion. If this is a cutaneous lesion it must be at least 10 mm by caliper measure. 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 scan. Bone lesions are not considered measurable.
3) Patients may be previously untreated or may have received one prior systemic chemotherapy. Prior treatment with immunotherapy or vaccine is allowed provided there is documentation of disease progression. Prior treatment with hepatic arterial chemotherapy infusion/perfusion or chemoembolization of liver metastasis is allowed as long as there is extrahepatic disease or progression of the liver metastasis after regional therapy. Patient must not have been previously treated with taxanes. Patients who have been treated with high dose chemotherapy plus stem cell rescue are also ineligible.
4) At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during therapy. If progression occurred during therapy, patient must have recovered from any side effects before starting Taxoprexin.
5) At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow and 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 >/= 13 years of age. Safety of Taxoprexin has not been studied adequately in younger patients.
9) Patients must have adequate liver and renal function as defined by total bilirubin no greater than the institution’s upper normal limit, transaminase levels (i.e., ALT and AST) no higher than 1.5 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 using the following formula: Male : Clcr (ml/min) = (140 - age ) x (tbw)(kg) devided by 72 x serum creatinine(mg/dl) Female : Clcr (ml/min) = 0.85 x ( 140 - age ) x (tbw)(kg) devided by 72 x serum creatinine(mg/dl).
10) Patients must have adequate bone marrow function as defined by an absolute neutrophil count >/= 1,500/mm^3 , and platelet count >/= 100,000/mm^3 .
11) Life expectancy of at least 3 months.
12) 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.
1) Patients who have received prior therapy with any taxane.
2) Patients whose primary site was not the choroid.
3) 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.
4) 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
5) 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.
6) Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
7) Patients with current peripheral neuropathy of any etiology that is greater than grade one.
8) 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.
9) Patients with a known hypersensitivity to Cremophor.
10) Patients with one or more of the following as the only manifestations of disease are ineligible: Osteoblastic 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.
11) Patients with Gilbert’s Syndrome.
12) Patients must not have had major surgery including l. node dissection, resection of melanoma metastatic to an organ or other surgical procedures that require hospitalization and administration of general anesthesia within the past 14 days.
13) Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
14) Known HIV disease or infection.
Information and next steps
Agop Y. Bedikian
Melanoma Medical Oncology
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