Taxoprexin® Treatment for Advanced Eye Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00244816 |
Recruitment Status :
Completed
First Posted : October 27, 2005
Last Update Posted : January 24, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
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Metastatic Melanoma | Drug: Taxoprexin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Open-Label Study of Weekly Taxoprexin® (DHA-paclitaxel) Injection as Treatment of Patients With Metastatic Uveal (Choroidal) Malignant Melanoma |
Study Start Date : | October 2005 |
Study Completion Date : | April 2007 |

- Response Rate
- Time to progression
- Time to treatment failure
- Survival

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have histologic or cytologic confirmation of malignant eye melanoma, and documented metastatic disease.
- Patients must have at least one unidimensionally measurable lesion.
- 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.
- At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
- At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow and prior adjuvant chemotherapy.
- Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
- Patients must have ECOG performance status of 0 - 2.
- Patients must be at least 13 years of age.
- Patients must have adequate liver and renal function.
- Patients must have adequate bone marrow function.
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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:
- Patients who have received prior therapy with any taxane.
- Patients whose site of primary melanoma is not in the choroid(eye).
- 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.
- Patients with symptomatic brain metastasis (es).
- 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.
- Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
- Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
- Patients with unstable or serious concurrent medical conditions are excluded.
- Patients with a known hypersensitivity to Cremophor.
- Patients with Gilbert's Syndrome.
- Patients must not have had major surgery within the past 14 days.
- Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
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Known HIV disease or infection.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244816
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Director: | Mark A Falone, MD | American Regent, Inc. |
ClinicalTrials.gov Identifier: | NCT00244816 |
Other Study ID Numbers: |
P01-04-22 |
First Posted: | October 27, 2005 Key Record Dates |
Last Update Posted: | January 24, 2018 |
Last Verified: | January 2018 |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |