Metastatic Melanoma
Conditions
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.
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 Interleukin-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.
Interventions
DRUGTaxoprexin
Administered by intravenous infusion over 1 hour infusion weekly for the first five weeks of a six week cycle.
Sponsors
American Regent, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
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 Eastern Cooperative Oncology Group 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 expectancy 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR). | Assessed every 6 weeks, up to 24 months | Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression | Assessed every 6 weeks until progression or death, up to 24 months | Progression free survival time was defined as the time from the day of randomization to the start of documented progression, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the sum of longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions. |
| Time to Treatment Failure | Baseline to stopping treatment | Time to Failure was defined as the time from the day of randomization to the discontinuation of protocol treatment for any reason. |
| Overall Participant Survival | Up to 24 months | Overall survival was defined as the time from the day of randomization to participant death or last date that participant was known to be alive, whichever occurs first. Survival data was collected every two months while participants were off-study. |
Outcome results
None listed