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Phase II Study of VEGF Trap in Patients With Previously Treated Metastatic Breast Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
VEGF Trap in Treating Patients With Metastatic Breast Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase II | Treatment | Closed | 18 and over | NCCTG-N0537 N0537, NCT00369655 |
Objectives Primary - Assess the antitumor activity of VEGF Trap, in terms of tumor response rate, in patients with metastatic breast cancer who have
received ≤ 2 prior chemotherapy regimens for metastatic disease, including a taxane
and/or anthracycline.
- Assess the 6-month progression-free survival rate in patients treated with VEGF Trap.
Secondary - Describe the adverse event profile (grade using the NCI CTCAE version 3.0)
of VEGF Trap in these patients.
- Describe the progression-free survival times in patients treated with VEGF Trap.
- Describe the overall survival of patients treated with VEGF Trap.
- Describe the duration of response in patients treated with VEGF Trap.
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
- See Disease Characteristics
- Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting allowed
- No prior bevacizumab
- More than 4 weeks since prior chemotherapy, endocrine therapy, experimental drug therapy, or immunotherapy and recovered
- More than 4 weeks since prior major surgery or open biopsy
- More than 7 days since prior core biopsy
- More than 2 weeks since prior radiotherapy, except if to a nontarget lesion only
- Prior radiotherapy to a target lesion allowed only if there has been clear progression
of the lesion since radiotherapy was completed
- Prior single-dose palliative radiotherapy within the past 2 weeks allowed
- No concurrent major surgery
- No concurrent trastuzumab
- Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met:
- INR in-range (usually between 2 and 3) on a stable dose of oral anticoagulant
or on a stable dose of low molecular weight heparin
- No active bleeding or pathological condition that carries a high risk of
bleeding (e.g., tumor involving major vessels or known varices)
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent participation in another investigational clinical trial
- No other concurrent chemotherapeutic agents, endocrine therapy, biologic agents, radiotherapy, or other nonprotocol antitumor therapy
Patient Characteristics:
- Male or female
- Menopausal status not specified
- ECOG performance status 0-1
- Life expectancy > 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin > 8.0 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Urine protein:creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No significant traumatic injury within the past 4 weeks
- No history of allergy or hypersensitivity to Chinese hamster ovary cell products or
other recombinant human antibodies, drug product excipients, or agents
chemically or biologically similar to VEGF Trap
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 28 days
- No nonhealing wound, fracture, or ulcer
- No stage III or IV invasive, nonbreast malignancy within the past 5 years
- No history of lung carcinoma of squamous cell type
- No clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident or stroke within the past 6 months
- Uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg OR
systolic BP > 180 mm Hg if diastolic blood pressure < 90 mm Hg on ≥ 2 separate occasions within the past 3 months
- Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
- New York Heart Association class III or IV cardiovascular disease
- Serious cardiac arrhythmia requiring medication
- Peripheral vascular disease ≥ grade 2 within the past 6 months
- Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
- No evidence of bleeding diathesis or uncontrolled coagulopathy
- No active, unresolved infection
- No serious concurrent medical condition that would preclude study participation
- No other condition or circumstance that would preclude compliance with study requirements
Expected Enrollment 45A total of 45 patients will be accrued for this study. Outcomes Primary Outcome(s)Tumor response rate as measured by RECIST criteria Progression-free survival rate at 6 months
Secondary Outcome(s)Adverse event profile as assessed by NCI CTCAE version 3.0 Time to disease progression Overall survival Duration of response
Outline This is a multicenter study. Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3-6 months for up to 5 years.
Trial Contact Information
Trial Lead Organizations North Central Cancer Treatment Group | | | Edith Perez, MD, Protocol chair | | | | Kendrith Rowland, MD, Protocol co-chair | | | | Donald Northfelt, MD, FACP, Protocol co-chair | | | |
Registry Information | | Official Title | | Phase II Trial of VEGF Trap in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and/or Taxane | | Trial Start Date | | 2007-01-12 | | Trial Completion Date | | 2007-12-15 (estimated) | | Registered in ClinicalTrials.gov | | NCT00369655 | | Date Submitted to PDQ | | 2006-06-07 | | Information Last Verified | | 2008-11-24 | | NCI Grant/Contract Number | | CA25224 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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