Taxoprexin Treatment for Advanced Skin Melanoma

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00249262
First received: November 3, 2005
Last updated: January 14, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Metastatic Melanoma
Drug: Taxoprexin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • Time to progression
  • Time to treatment failure
  • Survival

Estimated Enrollment: 30
Study Start Date: October 2005
Estimated Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249262

Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Director: Agop Bedikian, MD M.D. Anderson Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00249262     History of Changes
Obsolete Identifiers: NCT00411918
Other Study ID Numbers: P01-04-21
Study First Received: November 3, 2005
Last Updated: January 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 21, 2014