Phase III Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma
Taxoprexin
+ Dacarbazine
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: December 6, 2002
Actual date on which the first participant was enrolled.This was a randomized, multi-center, open-label Phase III study in patients with histologically confirmed metastatic malignant melanoma. Patients received either Taxoprexin® at a starting dose of 900 mg/m2 intravenously by 2-hour infusion on Day 1 every 3 weeks or dacarbazine at a starting dose of 1000 mg/m2 intravenously over at least 30 minutes once every 3 weeks. Treatment continued until progression of disease, intolerable toxicity, refusal of continued treatment by the patient, or, in the investigator's opinion, treatment discontinued. Disease status was assessed every 6 to 8 weeks using standard imaging techniques. All images were forwarded to the sponsor and archived. Following the end of protocol treatment, further treatment was at the investigator's discretion but no cross-over was planned. All patients were followed until death
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.393 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 Eastern Cooperative Oncology Group 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location