- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00255762
Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Phase II Trial of Carboplatin, Weekly Paclitaxel and Biweekly Bevacizumab in Patients With Unresectable Stage IV Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: Primary I. Determine the anti-tumor activity of carboplatin, paclitaxel, and bevacizumab, in terms of progression-free survival, in patients with unresectable stage IV melanoma.
II. Determine the toxicity profile of this regimen in these patients.
Secondary I. Determine the distribution of overall survival times in patients treated with this regimen.
II. Determine the response rate in patients treated with this regimen. III. Determine the changes in blood levels of vascular endothelial growth factor in patients treated with this regimen.
IV. Determine the changes in immune homeostasis in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- North Central Cancer Treatment Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed melanoma
- Unresectable stage IV disease
- Evidence of metastatic disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No radiologically confirmed invasion of adjacent organs (e.g., duodenum or stomach)
- No tumor invasion of major blood vessels
- No history of primary brain tumor or other CNS disease
- No brain metastases by MRI or CT scan
- Performance status - ECOG 0-2
- More than 4 months
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL (transfusion allowed)
- No active bleeding
- Bilirubin ≤ 1.5 mg/dL
- AST ≤ 3 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- INR ≤ 1.5 times ULN
- PTT normal
- No known esophageal varices
- Creatinine ≤ 1.5 times ULN
- Urine protein creatinine ratio ≤ 0.5
- Urine protein < 1 g/24-hr urine collection
- No New York Heart Association class II-IV congestive heart failure
- No serious cardiac arrhythmia requiring medication
- No myocardial infarction within the past 6 months
- No unstable angina within the past 6 months
- No clinically significant peripheral vascular disease
- No uncontrolled hypertension (i.e., blood pressure ≥ 150/90 mmHg despite antihypertensive therapy)
- No clinically significant stroke within the past 6 months
- No deep vein thrombosis within the past year
- No other vascular abnormality
- No pulmonary embolus within the past year
- No history of abdominal fistula
- No gastrointestinal perforation
- No intra-abdominal abscess within the past 4 weeks
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- No other pathological condition that would confer a high risk of bleeding
- No active infection requiring parenteral antibiotics
- No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture
- No peripheral neuropathy ≥ grade 2
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs
- No uncontrolled seizures
- No other uncontrolled illness
- No significant traumatic injury within the past 4 weeks
No prior antivascular endothelial growth factors (VEGF), including any of the following:
- Bevacizumab
- VEGF Trap
- Anti-VEGF receptor monoclonal antibody
- Small molecular tyrosine kinase inhibitors of VEGF receptors
- No more than 1 prior systemic chemotherapy regimen
- No prior carboplatin or paclitaxel
- No other concurrent chemotherapy
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to > 25% of bone marrow
- No concurrent radiotherapy
- At least 4 weeks since prior major surgical procedure or open biopsy
- At least 1 week since prior fine-needle aspiration or core biopsy
- No concurrent major surgery
- More than 4 weeks since prior systemic therapy
No concurrent full-dose oral or parenteral anticoagulation
- No concurrent antiplatelet therapy except low-dose aspirin (i.e., 81 mg of oral aspirin daily) allowed
- No other concurrent experimental drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (carboplatin, paclitaxel, bevacizumab)
Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Correlative studies
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: Time from registration to documentation of disease progression, assessed up to 8 weeks
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Constructed using the properties of the binomial distribution.
Estimated using the Kaplan-Meier method.
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Time from registration to documentation of disease progression, assessed up to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmed tumor response (complete response or partial response)
Time Frame: Up to 5 years
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A ninety percent confidence interval for the true proportion of confirmed tumor responses will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution.
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Up to 5 years
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Clinical response rate
Time Frame: Up to 5 years
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A ninety percent confidence interval for the true clinical response rate will be calculated.
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Up to 5 years
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Overall survival
Time Frame: Time is defined as the time from registration to death due to any cause, assessed up to 5 years
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The distribution of survival time will be estimated using the method of Kaplan-Meier.
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Time is defined as the time from registration to death due to any cause, assessed up to 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Svetomir Markovic, North Central Cancer Treatment Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Carboplatin
- Paclitaxel
- Antibodies
- Immunoglobulins
- Bevacizumab
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
Other Study ID Numbers
- NCI-2012-01823 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA025224 (U.S. NIH Grant/Contract)
- CDR0000449967
- NCCTG-N047A (Other Identifier: North Central Cancer Treatment Group)
- N047A (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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