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Taxoprexin Treatment for Advanced Skin Melanoma

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. Identifier: NCT00249262
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : January 24, 2018
Information provided by:
American Regent, Inc.

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 malignant melanoma being treated with weekly Taxoprexin® Injection.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: Taxoprexin Phase 2

Detailed Description:
This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with metastatic malignant melanoma who have not received cytotoxic agents for advanced disease. 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.

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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 First Line Treatment of Patients With Metastatic Non-choroidal Melanoma
Study Start Date : October 2005
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Time to progression
  2. Time to treatment failure
  3. Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease.
  2. Patients must have at least one measurable lesion.
  3. Patients must not have received prior systemic chemotherapy for metastatic disease. 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. Patients must have ECOG performance status of 0 - 2.
  7. Patients must be > 13 years of age. The safety of Taxoprexin has not been adequately studied in younger patients.
  8. Patients must have adequate liver and renal function.
  9. Patients must have adequate bone marrow function.
  10. Life expatancy of at least 3 months
  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 whose primary site was 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00249262

Sponsors and Collaborators
American Regent, Inc.
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Study Director: Mark A Falone, MD American Regent, Inc.
Layout table for additonal information Identifier: NCT00249262    
Obsolete Identifiers: NCT00411918
Other Study ID Numbers: P01-04-21
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas