Clinical trial NCT00244816: Taxoprexin® Treatment for Advanced Eye Melanoma
Official title: Phase II Open-Label Study of Weekly Taxoprexin® (DHA-paclitaxel) Injection as Treatment of Patients With Metastatic Uveal (Choroidal) Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Melanoma
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate objective response rate and duration of response to weekly Taxoprexin®.

To evaluate the safety profile of weekly Taxoprexin® in this patient population.

To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic choroidal melanoma being treated with weekly Taxoprexin® Injection.

Detailed description: This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with metastatic choroidal melanoma who may be previously untreated or have received one prior systemic cytotoxic regimen for advanced disease. Patients may not have been treated previously with taxanes. Patients may have been previously treated with immunological agents including IL-2 and vaccines. Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.

Eligibility criteria: Inclusion Criteria:

1. Patients must have histologic or cytologic confirmation of malignant eye melanoma, and documented metastatic disease.
2. Patients must have at least one unidimensionally measurable lesion.
3. Patients may be previously untreated or may have received one prior systemic chemotherapy regimen for metastatic disease. Patients may not have been treated previously with taxanes. Prior treatment with immunotherapy or vaccine therapy is allowed.
4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
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 at least 13 years of age.
9. Patients must have adequate liver and renal function.
10. Patients must have adequate bone marrow function.
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.

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Exclusion Criteria:

1. Patients who have received prior therapy with any taxane.
2. Patients whose site of primary melanoma is not in the choroid(eye).
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).
5. Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. 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 (1).
8. Patients with unstable or serious concurrent medical conditions are excluded.
9. Patients with a known hypersensitivity to Cremophor.
10. Patients with Gilbert's Syndrome.
11. Patients must not have had major surgery within the past 14 days.
12. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
13. Known HIV disease or infection.

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Primary outcomes:
measure: Response Rate
Secondary outcomes:
measure: Time to progression
measure: Time to treatment failure
measure: Survival
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: American Regent, Inc.
name: Mark A Falone, MD
role: STUDY_DIRECTOR
References: