Bevacizumab and Temozolomide or Bevacizumab and Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00626405|
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
RATIONALE: Drugs used in chemotherapy, such as temozolomide, paclitaxel albumin-stabilized nanoparticle formulation, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether bevacizumab is more effective when given together with temozolomide or paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in killing malignant melanoma cells.
PURPOSE: This randomized phase II trial is studying the side effects of giving temozolomide together with bevacizumab and to see how well it works compared with giving bevacizumab together with paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in treating patients with stage IV malignant melanoma that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: bevacizumab Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Drug: temozolomide||Phase 2|
- To assess the anti-tumor activity, in terms of the percentage of patients who are treated with these regimens and who are progression-free at 6 months.
- To assess the safety profile of each treatment regimen.
- To estimate the response rate in patients treated with these regimens.
- To estimate the distribution of progression-free survival time and overall survival time of patients treated with these regimens.
- To examine the impact of therapy on angiogenesis and immune homeostasis.
OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1) and location of metastatic disease (M1a [skin or subcutaneous tissue or lymph node only] vs M1b [lung] vs M1c [other visceral sites]) and randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15. (closed to accrual 8/21/09)
- Arm II: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.
In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for VEGF plasma levels and analysis of changes in immune homeostasis.
Beginning at study entry, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Phase II Trial of Temozolomide (TMZ) and Bevacizumab or ABI-007 (ABX)/Carboplatin (CBDCA) and Bevacizumab in Patients With Unresectable Stage IV Malignant Melanoma|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||November 2012|
Experimental: Arm I
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.
Given IV over 30-90 minutes
Oral temozolomide on days 1-5
Experimental: Arm II
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.
Given IV over 30-90 minutes
Given IV over 30 minutes
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV over 30 minutes
- Progression-free Survival at 6 Months [ Time Frame: at 6 months ]The primary endpoint is the 6 month post registration Progression-free survival (PFS) rate. Progression-free survival time is defined as the time from registration to documentation of disease progression using the RECIST criteria. Patients who died without documentation of disease progression will be considered to have progressed at death unless there is sufficient documented evidence to conclude no progression occurred prior to death. All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 6 month PFS rate.
- Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval [ Time Frame: Up to 5 years ]
A confirmed tumor response is defined to be a Complete Response or Partial Response noted
> as the objective status on 2 consecutive evaluations at least 8
> weeks apart. The proportion of tumor responses will be
> estimated by the number of confirmed tumor responses divided
> by the total number of evaluable patients.
> Complete Response (CR): Disappearance of all target lesions
> Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
> Progression (PD): At least a 20% increase in the sum of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
> Stable Disease (SD): Neither sufficient shrinkage to Qualify for PR nor sufficient increase to Qualify for PD taking as reference the smallest sum LD. responses will be calculated assuming that the number of
> confirmed tumor responses follows a binomial distribution.
- Overall Survival [ Time Frame: Up to 5 years ]Overall 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626405
|Study Chair:||Svetomir Markovic, MD, PhD||Mayo Clinic|