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Phase II Open-Label Study of Weekly Taxoprexin (DHA-Paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-Choroidal Melanoma


Phase 2
13 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

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Trial Information

Phase II Open-Label Study of Weekly Taxoprexin (DHA-Paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-Choroidal Melanoma


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Principal Investigator

Agop Bedikian, MD

Investigator Role:

Study Director

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

P01-04-21

NCT ID:

NCT00249262

Start Date:

October 2005

Completion Date:

April 2007

Related Keywords:

  • Metastatic Melanoma
  • Melanoma

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