Status:
COMPLETED
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
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 b...
Detailed Description
OBJECTIVES: Primary * 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 p...
Eligibility Criteria
Inclusion
- 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 \< 1.0 at screening ORproteinuria \< 2+ by urine dipstick or protein ≤ 1 g by 24-hour urine collection
- Negative serum pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Active infection requiring parenteral antibiotics
- Poorly controlled high blood pressure (≥ 150 mm Hg systolic and/or100 mm Hg diastolic) despite treatment
- NYHA class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Myocardial infarction or unstable angina within the past 6 months
- Clinically significant peripheral vascular disease
- Deep venous thrombosis or pulmonary embolus within the past year
- Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices)
- Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture
- Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 6 months
- History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.)
- Clinically significant stroke or TIA within the past 6 months
- Seizures not controlled with standardmedical therapy
- Peripheral neuropathy ≥ grade 2
- History of other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treatable with local resection only or carcinoma in situ of the cervix
- Significant traumatic injury within the past 4 weeks
- History of hypertensive crisis or hypertensive encephalopathy
- Active or recent (≤ 30 days) history of hemoptysis (≥ ½ teaspoon of bright red blood per episode)
- Known hypersensitivity to any of the components of bevacizumab
- Known to be HIV positive
- Current or known history of hepatitis
- Prior adjuvant chemotherapy and/or immunotherapy for this cancer allowed
- No prior treatment with agents disrupting VEGF activity (i.e., bevacizumab,VEGF-trap, anti-VEGFR Mab)
- No ongoing need for full-dose oral or parenteral anticoagulation
- No ongoing anti-platelet treatment other than low-dose aspirin(i.e., aspirin 81 mg daily)
- No other investigational agents within the past 4 weeks
- No major surgical procedure or open biopsy within the past 4 weeks
- No fine needle aspirations or core biopsies within the past 7 days
- No prior chemotherapy in the metastatic setting
- No prior treatment with sunitinib malate or sorafenib
- No prior treatment with any taxane-based chemotherapy
- Patients who have had \> 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
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00626405
Start Date
August 1 2008
End Date
November 1 2012
Last Update
May 1 2018
Active Locations (259)
Enter a location and click search to find clinical trials sorted by distance.
1
Providence Cancer Center
Anchorage, Alaska, United States, 99508
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
3
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
4
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019