Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
- Conditions
- Melanoma (Skin)
- Interventions
- Registration Number
- NCT00404235
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery.
- Detailed Description
OBJECTIVES:
Primary
* Assess the safety and antitumor activity of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) in patients with unresectable stage IV melanoma who have not received prior chemotherapy for their metastatic disease. (Cohort 1)
* Assess the safety and antitumor activity of this regimen in patients with unresectable stage IV melanoma who have received prior chemotherapy for their metastatic disease. (Cohort 2)
Secondary
* Describe the impact of this regimen on parameters of immune function and angiogenesis in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no).
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description paclitaxel + carboplatin paclitaxel albumin-stabilized nanoparticle formulation Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers. After completion of study treatment, patients are followed periodically for up to 2 years. paclitaxel + carboplatin carboplatin Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers. After completion of study treatment, patients are followed periodically for up to 2 years.
- Primary Outcome Measures
Name Time Method Tumor Response Rate, as Measured by RECIST Criteria Up to 2 years The RECIST criteria will be used for response assessments. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
- Secondary Outcome Measures
Name Time Method Time to Disease Progression Up to 2 years Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Survival Time Up to 2 years Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Duration of Response Up to 3 years Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.
Number of Treatment Cycles Administered Up to 2 years Number of treatment cycles administered is defined to be the number of treatment cycles administered until the patient is removed from treatment due to progression, toxicity, or refusal. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Trial Locations
- Locations (151)
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Scroll for more (141 remaining)Mayo Clinic Scottsdale🇺🇸Scottsdale, Arizona, United States