Clinical trial NCT00087776: Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma
Official title: Phase III Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Melanoma
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2004-07-16
Enrollment: 575
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* Patients must have malignant melanoma, and documented metastatic disease.
* Patients must have at least one unidimensionally measurable lesion.
* Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression.
* At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during immunotherapy.
* At least 4 weeks (28 days) since any prior radiotherapy.
* Lesions being used to assess disease status may not have been radiated.
* Patients must have ECOG performance status of 0 - 2.
* Patients must be \>= 18 years of age.
* Patients must have adequate renal and liver function
* Patients must have adequate bone marrow function.
* Life expectancy of at least 3 months.
* 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:

* Patients who have received prior therapy with any taxane or dacarbazine.
* Patients whose primary site is the 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 cured by surgery alone with a disease-free survival longer than 5 years.
* Patients with uncontrolled brain metastasis.
* 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 1.
* Patients with unstable or serious concurrent medical conditions are excluded.
* Patients with a known hypersensitivity to Cremophor.
* Patients must not have had recent major surgery within the past 14 days or large field radiation therapy, chemotherapy, endocrine therapy in the last 28 days, or biologic therapy in the last 42 days.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals, Inc.
state: Pennsylvania
Study officials:
References: