Phase 2 N=95 Randomized Double-blind Treatment

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

Melanoma (Skin)

Bottom Line

View on ClinicalTrials.gov: NCT00626405 ↗

Enrolled (actual)

Serious AEs

26.6%

Results posted

May 2018

Primary outcome: Primary: Progression-free Survival at 6 Months — 32.8; 56.1 % of patients alive and progression free

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab (Biological); carboplatin (Drug); paclitaxel albumin-stabilized nanoparticle formulation (Drug); temozolomide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alliance for Clinical Trials in Oncology
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free Survival at 6 Months	32.8; 56.1	—
SECONDARY Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval	23.8; 33.3	—
SECONDARY Overall Survival	12.3; 13.9	—

Summary

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.

Eligibility Criteria

Histologic confirmed diagnosis of malignant melanoma
Stage IV disease
Not amenable tosurgery
Measurable disease with at least one lesion whose longest diameter canbe measured as ≥ 20 mm by CT or MRI scans OR ≥ 10 mm by spiral CT
No disease that is measurable by physical examination only
No brain metastases per MRI or CT
No radiographically documented invasion of adjacent organs(duodenum, stomach, etc.) or tumor invading major blood vessels
ECOG performance status 0-1
Life expectancy ≥ 4 months
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL (transfusion allowed)
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL (unless Gilbert syndrome)
AST ≤ 2.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
Urine protein: creatinine ratio 25% of their functional bone marrow irradiated are not eligible for this trial
No adjuvant radiation therapy within the past 4 weeks
More than 2 weeks since prior and no concurrent palliative radiation therapy
No concurrent major surgical procedure
No concurrent participation in another clinical study for procedures or agents that treat the same primary study malignancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00626405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.